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Bur Holder Box
EUDAMEDClass I (EU MDR)
Ref BC01Model BB01,BB02,BB03,BB09,BC01,BF01,BF06Ref BB03
Identity
- Trade Name
- Bur Holder Box EUDAMED
- Device Name
- Bur Holder Box EUDAMED
- Model / Reference
- BB01,BB02,BB03,BB09,BC01,BF01,BF06 EUDAMEDBC01 EUDAMEDBB03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000601 EUDAMED06954454000588 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 (2)
- EUDAMED 21e70773-e4b4-4cf9-a607-e255be0b06c4 61 fields · synced Oct 6, 2026
- EUDAMED 1047618b-1d22-49cc-bc41-118b2f6d6daa 61 fields · synced May 18, 2026