Identity
- Trade Name
- Gutta-percha Obturation System EUDAMEDREFINE FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Gutta-percha Obturation System EUDAMEDEndodontic obturation system FDA UDI
- Model / Reference
- MaxFill-G EUDAMEDMaxFill-P FDA UDI
- Description
- Endodontic obturation system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971560453428 EUDAMEDFDA UDI
- Basic UDI-DI
- 697156045MFGRE EUDAMED
- Direct Marketing DI
- 06971560453428 EUDAMED
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gutta-percha Obturation System by Guilin Refine Medical Instrument Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697156045MFGRE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 8f2d9464-e416-4f4a-9c17-2d35795f6ef1 61 fields · synced Jul 15, 2026
- FDA UDI 3cf9428f-1a46-47e8-8862-d50ff1335cbb 33 fields · synced May 30, 2026