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Compule Gun Purple Gala Unodent
EUDAMEDClass I (EU MDR)
Ref 116152UNODENTModel 116150UNODENT
Identity
- Trade Name
- Compule Gun Purple Gala Unodent EUDAMED
- Device Name
- Compule Gun Light Grey Unodent EUDAMED
- Model / Reference
- 116150UNODENT EUDAMED116152UNODENT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454013717 EUDAMED
- Basic UDI-DI
- 69544540COGU001QB EUDAMED
- Direct Marketing DI
- 06954454013717 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Compule Gun Purple Gala Unodent 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 | 69544540COGU001QB | 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 aadea468-2e8f-41ef-85c5-460c6238e154 61 fields · synced Oct 6, 2026