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Gutta-percha Tip
EUDAMEDClass IIa (EU MDR)
Ref 3504Model 3504,4004,4504,5004,5506,5508,5510,6012,5508L
Identity
- Trade Name
- Gutta-percha Tip EUDAMED
- Device Name
- Gutta-percha Tip EUDAMED
- Model / Reference
- 3504,4004,4504,5004,5506,5508,5510,6012,5508L EUDAMED3504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971560457297 EUDAMED
- Basic UDI-DI
- 697156045TGOT4 EUDAMED
- Direct Marketing DI
- 06971560457297 EUDAMED
- EMDN Code
- A010699 DENTISTRY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Gutta-percha Tip by Guilin Refine Medical Instrument Co., Ltd. — Class IIa — 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 | 697156045TGOT4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guilin Refine Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012204
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED a3a5d807-a9f7-4a0b-8e8c-36939d4f364a 61 fields · synced Jun 20, 2026