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669 device results listed.

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Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)

GECEA-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGECEA-401aBD
Basic UDI-DI: B-OGGECEA-401aBD
Reference: GECEA-401a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDTRO-402bZH
Basic UDI-DI: B-OGGDTRO-402bZH
Reference: GDTRO-402b
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDPCT-T402aBZ
Basic UDI-DI: B-OGGDPCT-T402aBZ
Reference: GDPCT-T401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Strip (Whole Blood/Serum/Plasma)

GDPCT-T401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDPCT-T401aBW
Basic UDI-DI: B-OGGDPCT-T401aBW
Reference: GDPCT-T401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Oral Fluid Drug Test Square Cube

GBDSA-XXXXRX

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGBDSA-XXXXRX6H
Basic UDI-DI: B-OGGBDSA-XXXXRX6H
Reference: GBDSA-XXXXRX
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

GBDOA-1X5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGBDOA-1X5DN
Basic UDI-DI: B-OGGBDOA-1X5DN
Reference: GBDOA-1X5
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette (Whole Blood)

GIVD-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIVD-402b76
Basic UDI-DI: B-GIVD-402b76
Reference: GIVD-402b
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette (Whole Blood)

GIVD-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIVD-402a74
Basic UDI-DI: B-GIVD-402a74
Reference: GIVD-402a
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Cassette (Urine)

GIHSA-103a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIHSA-103a4D
Basic UDI-DI: B-GIHSA-103a4D
Reference: GIHSA-103a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Cassette (Urine)

GIHSA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIHSA-102a4A
Basic UDI-DI: B-GIHSA-102a4A
Reference: GIHSA-102a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Strip (Urine)

GIHSA-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIHSA-101a47
Basic UDI-DI: B-GIHSA-101a47
Reference: GIHSA-101a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor IgM Rapid Test Cassette (Serum/Plasma)

GGRF(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GGRF(IgM)-302aWT
Basic UDI-DI: B-GGRF(IgM)-302aWT
Reference: GGRF(IgM)-302a
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE Rapid Test Cassette (Serum/Plasma)

GGIGE-302a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GGIGE-302aX2
Basic UDI-DI: B-GGIGE-302aX2
Reference: GGIGE-302a
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Transferrin Rapid Test Device (Feces)

GETF-606a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GETF-606a5A
Basic UDI-DI: B-GETF-606a5A
Reference: GETF-606a
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Transferrin Rapid Test Cassette (Feces)

GETF-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GETF-602a4W
Basic UDI-DI: B-GETF-602a4W
Reference: GETF-602a
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Transferrin Rapid Test Strip (Feces)

GETF-601a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GETF-601a4T
Basic UDI-DI: B-GETF-601a4T
Reference: GETF-601a
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole blood/Serum/Plasma)

GEPSA-402a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEPSA-402a6T
Basic UDI-DI: B-GEPSA-402a6T
Reference: GEPSA-402a
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Rapid Test Strip (Whole blood/Serum/Plasma)

GEPSA-401a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEPSA-401a6Q
Basic UDI-DI: B-GEPSA-401a6Q
Reference: GEPSA-401a
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Rapid Test Cassette (Serum/Plasma)

GEPSA-302a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEPSA-302a6L
Basic UDI-DI: B-GEPSA-302a6L
Reference: GEPSA-302a
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Rapid Test Strip (Serum/Plasma)

GEPSA-301a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEPSA-301a6H
Basic UDI-DI: B-GEPSA-301a6H
Reference: GEPSA-301a
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details