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Impression Trays
EUDAMEDClass I (EU MDR)
Ref DisposableModel Disposable(GD-1271 --GD-1296,GD-1331--GD-1340);Autoclavable(GD-1311--GD-1320);Implant Trays(GD-1321--GD-1330);Bite Tray(GD-1221--GD-1225,GD-1231--GD-1236,GD-1241--GD-1245);GD-1381--GD-1390Ref Bite TrayRef AutoclavableRef Dentulous Jaw TraysRef Implant Trays
Identity
- Trade Name
- IMPRESSION TRAYS EUDAMED
- Model / Reference
- Disposable(GD-1271 --GD-1296,GD-1331--GD-1340);Autoclavable(GD-1311--GD-1320);Implant Trays(GD-1321--GD-1330);Bite Tray(GD-1221--GD-1225,GD-1231--GD-1236,GD-1241--GD-1245);GD-1381--GD-1390 EUDAMEDDisposable EUDAMEDBite Tray EUDAMEDAutoclavable EUDAMEDDentulous Jaw Trays EUDAMEDImplant Trays EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975652007322 EUDAMED06975652007162 EUDAMED06975652007544 EUDAMED06975652007445 EUDAMED06975652007018 EUDAMED06978502820850 EUDAMED06975652007100 EUDAMED06975652007438 EUDAMED06978502820805 EUDAMED06978502828672 EUDAMED06975652007131 EUDAMED06978502820867 EUDAMED06975652007254 EUDAMED06978502820881 EUDAMED06978502828689 EUDAMED06975652007414 EUDAMED06978502828641 EUDAMED06975652007247 EUDAMED06975652007315 EUDAMED06975652007285 EUDAMED06975652007025 EUDAMED06975652007087 EUDAMED06975652007292 EUDAMED06978502820843 EUDAMED06975652007551 EUDAMED06978502820775 EUDAMED06975652007063 EUDAMED06978502820898 EUDAMED06978502828665 EUDAMED06975652007032 EUDAMED06975652007605 EUDAMED06978502820836 EUDAMED06978502828634 EUDAMED06975652007513 EUDAMED06978502820768 EUDAMED06975652007155 EUDAMED06975652007568 EUDAMED06975652007261 EUDAMED06975652007216 EUDAMED06978502820812 EUDAMED06975652007490 EUDAMED06975652007476 EUDAMED06975652007520 EUDAMED06975652007186 EUDAMED06975652007599 EUDAMED06978502820874 EUDAMED06975652007278 EUDAMED
- Basic UDI-DI
- 697565200IT001FD EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDGreece 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 impression tray, single-use
Impression Trays by Hubei Guarddent Medical Technology 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 | 697565200IT001FD | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (47)
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