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527 device results listed.

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OPTI CCA-TS2 Hb Cal Cassette

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000718
Basic UDI-DI: B-00894472000718
Reference: BP7653
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA-TS2 MULTI-LEVEL SRC

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000701
Basic UDI-DI: B-00894472000701
Reference: BP7652
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA B-60 CASSETTE

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000695
Basic UDI-DI: B-00894472000695
Reference: BP7586
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA B-LAC CASSETTE

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000688
Basic UDI-DI: B-00894472000688
Reference: BP7561
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA E-GLU CASSETTE

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000275
Basic UDI-DI: B-00894472000275
Reference: BP7564
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA E-CL CASSETTE

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000268
Basic UDI-DI: B-00894472000268
Reference: BP7559
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA E-CA CASSETTE

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000251
Basic UDI-DI: B-00894472000251
Reference: BP7560
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA CASSETTES B

OPTI CCA B Cassette

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000237
Basic UDI-DI: B-00894472000237
Reference: BP7562
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CHECK PLUS

OPTI CCA OPTI CHECK PLUS

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000114
Basic UDI-DI: B-00894472000114
Reference: HC7009
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CHECK

OPTI CCA OPTI CHECK

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000107
Basic UDI-DI: B-00894472000107
Reference: HC7008
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI Hb Cal Cassette

OPTIC CCA, OPTI CCA TS Hb Cal Cassette

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000053
Basic UDI-DI: B-00894472000053
Reference: BP7542
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA SRC LEVEL 1

OPTI CCA, OPTI CCA-TS SRC LEVEL 1

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000046
Basic UDI-DI: B-00894472000046
Reference: BP7536
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA SRC LEVEL 3

OPTI CCA, OPTI CCA TS SRC LEVEL 3

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000039
Basic UDI-DI: B-00894472000039
Reference: BP7543
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA SRC LEVEL 2

OPTI CCA, OPTI CCA TS SRC LEVEL 2

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000022
Basic UDI-DI: B-00894472000022
Reference: BP7554
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CALIBRATION GAS

OPTI CCA, OPTI CCA -TS CALIBRATION GAS

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000015
Basic UDI-DI: B-00894472000015
Reference: BP7001
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 16:01

Manufacturer products Authorised representative products Authorised representative actors View details

DAY Dilution Plates

09310-20

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001888
Basic UDI-DI: 9354330009310YX
Reference: 09310-20
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

DAY Pipetting Tips

09020-20

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001789
Basic UDI-DI: 9354330009020YK
Reference: 09020-20
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

DAYdiscs

09210-16

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001772
Basic UDI-DI: 9354330009210YS
Reference: 09210-16
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

08809378689266

PANAMAX™ Blood DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: HLB PANAGENE
Manufacturer SRN: KR-MF-000042004
UDI-DI: 08809378689266
Basic UDI-DI: 88093786PNAK6003S
Reference: PNAK-6001
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

08809378689181

PANAMAX™ FFPE RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: HLB PANAGENE
Manufacturer SRN: KR-MF-000042004
UDI-DI: 08809378689181
Basic UDI-DI: 88093786PNAK4003G
Reference: PNAK-4001
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details