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Blood Glucose Control Solution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 1A004DDModel Level 2
Identity
- Trade Name
- Blood Glucose Control Solution EUDAMED
- Device Name
- Blood Glucose Control Solution EUDAMED
- Model / Reference
- Level 2 EUDAMED1A004DD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175027293 EUDAMED
- Basic UDI-DI
- B-06934175027293 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Ireland 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 Control Solution by Changsha Sinocare Inc. — Class IVD Annex II List B — 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-06934175027293 | Class IVD Annex II List B | 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 16bf3416-4e8f-4455-8372-a65a339b98b8 61 fields · synced Jun 18, 2026