Identity
- Trade Name
- HbA1c Assay Kit (HPLC) EUDAMED
- Device Name
- HbA1c Assay Kit (HPLC) EUDAMED
- Model / Reference
- BT07002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260206506 EUDAMED
- Basic UDI-DI
- B-06933260206506 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HbA1c Assay Kit (HPLC) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — 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-06933260206506 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4c158f7d-f7cb-4142-8ac9-a5b867fb2341 61 fields · synced Jun 18, 2026
- EUDAMED 41f7cc75-23d9-4b83-9adb-70af1c3a688b 61 fields · synced Jun 11, 2026