Identity
- Trade Name
- Microtome Blade EUDAMED
- Device Name
- Microtome Blade EUDAMED
- Model / Reference
- BH3 EUDAMED130.012.003-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971182570114 EUDAMED
- Basic UDI-DI
- 69711825720VN EUDAMED
- EMDN Code
- Z1212020502 MICROBLADE MICROKERATOMES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
New Device
No
EUDAMED
Microtome Blade by Dakewe (Shenzhen) Medical Equipment 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 | 69711825720VN | Class A | Active |
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Manufacturer
- Manufacturer
- Dakewe (Shenzhen) Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000009696
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5fe7728f-bbfa-4171-8d61-5900e912b2a2 61 fields · synced Jul 24, 2026