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Impression Trays
EUDAMEDClass I (EU MDR)
Ref AutoclavableModel 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
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 EUDAMEDAutoclavable EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975652007506 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 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 (1)
- EUDAMED 8a463673-b5eb-48c0-8214-f1c728b52ccf 61 fields · synced Jun 19, 2026