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Root Canal Frame
EUDAMEDClass I (EU MDR)
Ref BF02Model BF02,BF03A,BF03B,BF04,BF05,BF0517
Identity
- Trade Name
- Root Canal Frame EUDAMED
- Device Name
- Dental Ruler EUDAMED
- Model / Reference
- BF02,BF03A,BF03B,BF04,BF05,BF0517 EUDAMEDBF02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001264 EUDAMED
- Basic UDI-DI
- 69544540MEGU001RK EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Dental appliance fabrication material, ceramic
Root Canal Frame by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69544540MEGU001RK | 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 67d6afd5-9968-4d9c-bdeb-0e4dea294c50 61 fields · synced Oct 8, 2026