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Blood Glucose and Uric Acid Meter
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 4B002Model SPUG
Identity
- Device Name
- Blood Glucose and Uric Acid Meter EUDAMED
- Model / Reference
- SPUG EUDAMED4B002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01B0112Y8 EUDAMED
- Basic UDI-DI
- B-01B0112Y8 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Glucose and Uric Acid Meter by Changsha Sinocare Inc. — Class IVD devices for self-testing — 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-01B0112Y8 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a38eb9db-5277-4b8d-a3dc-8e1c23ba505a 61 fields · synced Jun 19, 2026