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D-69750225319172CENSXR

Blood β-Ketone Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225319172CENSXR
Basic UDI-DI: B-69750225319172CENSXR
Reference: EN500R1、EN500R2、 EN500R3、 EN500R4
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analysis Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646URS001T9CW
Basic UDI-DI: B-697424646URS001T9CW
Reference: URS-1**1
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:16

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Urine Analysis Test Strip(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646URS000T7CM
Basic UDI-DI: B-697424646URS000T7CM
Reference: URS-1111
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:16

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BV pH Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PH001GSKD
Basic UDI-DI: B-697424646PH001GSKD
Reference: PH-6011/PH-6012
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

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BV pH Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PH000GQK4
Basic UDI-DI: B-697424646PH000GQK4
Reference: PH-6011/PH-6012
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Urine strip test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309294
Basic UDI-DI: B-69743840309294
Reference: 3034502
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

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Vaginitis Multi-Test(Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MVA001MF33
Basic UDI-DI: B-697424646MVA001MF33
Reference: MVA-6**1C/MVA-6**2C
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:10

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Vaginitis Multi-test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MVA000MD2S
Basic UDI-DI: B-697424646MVA000MD2S
Reference: MVA-6**1C/MVA-6**2C
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 17.07.2026 04:10

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Fecal Occult Blood FIA Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB000FKQ5Q
Basic UDI-DI: B-697424646FOB000FKQ5Q
Reference: FOB-5012F
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Faecal Occult Blood Rapid Test Kit(Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB000GCSL
Basic UDI-DI: B-697424646FOB000GCSL
Reference: FOB-5011/FOB-5012
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test(Milk)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC003DPPF
Basic UDI-DI: B-697424646ALC003DPPF
Reference: ALC-8011/ALC-8012/ALC-8014
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC002DMP4
Basic UDI-DI: B-697424646ALC002DMP4
Reference: ALC-7011/ALC-7012/ALC-7014
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC001DKNT
Basic UDI-DI: B-697424646ALC001DKNT
Reference: ALC-1011/ALC-1012/ALC-1014
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC000DHNG
Basic UDI-DI: B-697424646ALC000DHNG
Reference: ALC-1011/ALC-1012/ALC-1014
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test Kit(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC(S)000DHTJ
Basic UDI-DI: B-697424646ALC(S)000DHTJ
Reference: ALC-7011/ALC-7014
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Rapid Test Kit(Milk)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ALC(M)000DHQC
Basic UDI-DI: B-697424646ALC(M)000DHQC
Reference: ALC-8011/ALC-8014
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Adulteration(ADU) Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADU001ERSE
Basic UDI-DI: B-697424646ADU001ERSE
Reference: ADU-1061
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Adulteration Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADU000EPS5
Basic UDI-DI: B-697424646ADU000EPS5
Reference: ADU-1061
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

ACCU-ANSWER

UA01

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: Guilin Royalyze Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000038422
UDI-DI: D-697191378-UATSHP
Basic UDI-DI: B-697191378-UATSHP
Reference: UA01
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

ACCU-ANSWER

TC01

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: Guilin Royalyze Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000038422
UDI-DI: D-697191378-TCTSHS
Basic UDI-DI: B-697191378-TCTSHS
Reference: TC01
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details