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BGM-202 Blood Glucose Monitoring System
EUDAMEDClass A (EU MDR)
Ref BT0000701Model BGM-202
Identity
- Device Name
- BGM-202 Blood Glucose Monitoring System EUDAMED
- Model / Reference
- BGM-202 EUDAMEDBT0000701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260213221 EUDAMED
- Basic UDI-DI
- 69332602IT0100009A9 EUDAMED
- EMDN Code
- W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
BGM-202 Blood Glucose Monitoring System by Xiamen Biotime Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69332602IT0100009A9 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 43005b4f-4709-4182-9c57-d463cd5d7a4b 61 fields · synced Oct 6, 2026