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Blood Glucose Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref -Model SA-102
Identity
- Trade Name
- Blood Glucose Test Strips EUDAMED
- Device Name
- Blood Glucose Test Strips EUDAMED
- Model / Reference
- SA-102 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972480914839 EUDAMED
- Basic UDI-DI
- B-06972480914839 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Glucose Test Strips by Jiangxi Aicare Medical Technology Co., Ltd — 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-06972480914839 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Jiangxi Aicare Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000025838
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 3f48026e-3399-42cc-ada0-fff855aec7ce 61 fields · synced Jul 31, 2026