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Compule Dispenser Gun
EUDAMEDClass I (EU MDR)
Ref CG01Model SDG01,SDG02,CG01,CG02
Identity
- Trade Name
- Compule Dispenser Gun EUDAMED
- Device Name
- Dental material bullet dispenser EUDAMED
- Model / Reference
- SDG01,SDG02,CG01,CG02 EUDAMEDCG01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000243 EUDAMED
- Basic UDI-DI
- 69544540DMBD001JL EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Dispenser Gun 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 | 69544540DMBD001JL | 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 ca1a6e18-5be7-48fa-95d3-948750abb040 61 fields · synced Oct 6, 2026