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Bur Holder Box
EUDAMEDClass I (EU MDR)
Ref BB02Model BB01,BB02,BB03,BB09,BC01,BF01,BF06
Identity
- Trade Name
- Bur Holder Box EUDAMED
- Device Name
- Bur Holder Box EUDAMED
- Model / Reference
- BB01,BB02,BB03,BB09,BC01,BF01,BF06 EUDAMEDBB02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000571 EUDAMED
- Basic UDI-DI
- 69544540BUHB001NE EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Bur Holder Box by Huanghua Promisee Dental 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 | 69544540BUHB001NE | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 8994d404-34ff-4d67-b150-5d450b45e8d9 61 fields · synced Jun 19, 2026