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Tool Marker
EUDAMEDClass I (EU MDR)
Ref BFS000000029Model SA-02-MAK-03Ref BFS000000030Model SA-02-MAK-04
Identity
- Device Name
- Tool Marker EUDAMED
- Model / Reference
- SA-02-MAK-03 EUDAMEDBFS000000029 EUDAMEDSA-02-MAK-04 EUDAMEDBFS000000030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975130760138 EUDAMED06975130760145 EUDAMED
- Basic UDI-DI
- 697513076013J5 EUDAMED697513076014J7 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
Tool 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 | 697513076013J5 | 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 (2)
- EUDAMED 5fd0f18c-2e2c-4d08-a1dd-68349c350ca5 61 fields · synced Aug 2, 2026
- EUDAMED 46b83f9f-1091-4d10-a64d-6991967bd116 61 fields · synced May 19, 2026