Identity
- Device Name
- CA Marker EUDAMED
- Model / Reference
- SA-02-MAK-01 EUDAMEDBFS000000027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975130760114 EUDAMED
- Basic UDI-DI
- 697513076011HZ EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CA Marker by Beijing Yakebot Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697513076011HZ | Class I | Active |
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Manufacturer
- Manufacturer
- Beijing Yakebot Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038958
- Authorised Representative
- PureCE B.V. NL-AR-000006069
Sources (1)
- EUDAMED 06c9a7a8-1b63-44e0-97c6-69907510aed2 61 fields · synced Jun 17, 2026