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Urea (UREA) Test Kit (Urease-GLDH)
EUDAMEDClass IVD General (EU MDR)
Ref R1:48mL×2 R2:16mL×2（705）Ref R1:18mL×4 R2:6mL×4（707）Ref R1:40mL×3 R2:20mL×2（704）Ref R1:48mL×2 R2:16mL×2（713）Ref R1:18mL×4 R2:6mL×4（709）Ref R1:48mL×2 R2:16mL×2（798）Ref R1:60mL×2 R2:20mL×2（701）Ref R1:48mL×2 R2:16mL×2（715）Ref R1:18mL×1 R2:6mL×1（702）Ref R1:18mL×4 R2:6mL×4（796）Ref R1:60mL×2 R2:20mL×2（706）Ref R1:48mL×2 R2:16mL×2（716）
Identity
- Trade Name
- Urea (UREA) Test Kit (Urease-GLDH) EUDAMED
- Device Name
- Urea (UREA) Test Kit (Urease-GLDH) EUDAMED
- Model / Reference
- R1:48mL×2 R2:16mL×2（705） EUDAMEDR1:18mL×4 R2:6mL×4（707） EUDAMEDR1:40mL×3 R2:20mL×2（704） EUDAMEDR1:48mL×2 R2:16mL×2（713） EUDAMEDR1:18mL×4 R2:6mL×4（709） EUDAMEDR1:48mL×2 R2:16mL×2（798） EUDAMEDR1:60mL×2 R2:20mL×2（701） EUDAMEDR1:48mL×2 R2:16mL×2（715） EUDAMEDR1:18mL×1 R2:6mL×1（702） EUDAMEDR1:18mL×4 R2:6mL×4（796） EUDAMEDR1:60mL×2 R2:20mL×2（706） EUDAMEDR1:48mL×2 R2:16mL×2（716） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674863786 EUDAMED06971674863809 EUDAMED06971674863779 EUDAMED06971674863878 EUDAMED06971674863755 EUDAMED06971674863861 EUDAMED06971674863748 EUDAMED06971674863885 EUDAMED06971674863762 EUDAMED06971674863854 EUDAMED06971674863793 EUDAMED06971674863892 EUDAMED
- Basic UDI-DI
- B-06971674863786 EUDAMEDB-06971674863809 EUDAMEDB-06971674863779 EUDAMEDB-06971674863878 EUDAMEDB-06971674863755 EUDAMEDB-06971674863861 EUDAMEDB-06971674863748 EUDAMEDB-06971674863885 EUDAMEDB-06971674863762 EUDAMEDB-06971674863854 EUDAMEDB-06971674863793 EUDAMEDB-06971674863892 EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Urea (UREA) Test Kit (Urease-GLDH) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674863786 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (12)
- EUDAMED 55359d42-e8d9-440b-be90-a9d26da0cb3c 61 fields · synced Oct 6, 2026
- EUDAMED df8a7887-5d5d-4beb-8728-eac314c76557 61 fields · synced May 16, 2026
- EUDAMED 88a1e148-8259-4fc9-aa06-4383b3941ecd 61 fields · synced May 17, 2026
- EUDAMED 75ef381e-aaad-4340-b33d-e8ab2ab6e842 61 fields · synced May 17, 2026
- EUDAMED f58d2fa4-e4c1-4ef2-adea-8f7342e0590a 61 fields · synced May 17, 2026
- EUDAMED 5143fc98-c9f3-46f8-9468-c2ebb9ffe930 61 fields · synced May 17, 2026
- EUDAMED 49f7e2b1-636f-4ae5-b985-255455d5962d 61 fields · synced May 17, 2026
- EUDAMED ff4a04ff-5f2c-4558-9bb3-7395e989367c 61 fields · synced May 18, 2026
- EUDAMED a4360df4-adf4-476d-8cd9-a5bcb6c38edf 61 fields · synced May 18, 2026
- EUDAMED 9aa1d894-a33a-4674-ad5a-e4c4caa37cbf 61 fields · synced May 19, 2026
- EUDAMED 33d81d70-4efa-4910-8fe9-d86bc005d9c9 61 fields · synced May 19, 2026
- EUDAMED fe07bcba-7bc2-4690-992f-297b658f57ed 61 fields · synced May 19, 2026