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Implant Tray
EUDAMEDClass I (EU MDR)
Ref /Model IG04 Type I,IG04 Type II,IG06,IG0601,IG0602,IG0603,IG0604, IG0605,IG0606,IG07,IG0701,IG0702,IG0703,IG0704, IG0705,IG0706
Identity
- Trade Name
- Implant Tray EUDAMED
- Device Name
- Implant Tray EUDAMED
- Model / Reference
- IG04 Type I,IG04 Type II,IG06,IG0601,IG0602,IG0603,IG0604, IG0605,IG0606,IG07,IG0701,IG0702,IG0703,IG0704, IG0705,IG0706 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454006184 EUDAMED
- Basic UDI-DI
- 69544540IMTR002WK EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Implant Tray by Huanghua Promisee Dental 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 | 69544540IMTR002WK | 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 11814cf4-0219-46f6-bebb-ef57b4886ed4 61 fields · synced Jun 19, 2026