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Microalbumin and Creatinine Urinalysis Reagent Strips
EUDAMEDClass IVD General (EU MDR)
Ref ALB/CRE-U11
Identity
- Trade Name
- Microalbumin and Creatinine Urinalysis Reagent Strips EUDAMED
- Device Name
- Microalbumin and Creatinine Urinalysis Reagent Strips EUDAMED
- Model / Reference
- ALB/CRE-U11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804817749 EUDAMED
- Basic UDI-DI
- B-06952804817749 EUDAMED
- EMDN Code
- W0101060299 URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Microalbumin and Creatinine Urinalysis Reagent Strips by Assure Tech. (hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06952804817749 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a4078406-ec5b-43a3-80c2-3d03b1a4518a 61 fields · synced Jun 19, 2026