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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
- 06954454002346 EUDAMED06954454006160 EUDAMED06954454006412 EUDAMED06954454006139 EUDAMED06954454006177 EUDAMED06954454000786 EUDAMED06954454005200 EUDAMED06954454002377 EUDAMED06954454006153 EUDAMED06954454002339 EUDAMED06954454002384 EUDAMED
- Basic UDI-DI
- 69544540IMTR002WK EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDFinland EUDAMEDSpain EUDAMEDHungary EUDAMEDPoland 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 (11)
- EUDAMED 1426908c-4ed4-4a9d-9e3b-a20775e0fb06 61 fields · synced Jul 29, 2026
- EUDAMED 73ced50f-3ffb-4179-94bb-6db9247f563e 61 fields · synced May 17, 2026
- EUDAMED 293fcb2d-f233-4455-9acf-81af71d8aea0 61 fields · synced May 17, 2026
- EUDAMED 3c7df984-345f-48de-8ddc-97c2525062c9 61 fields · synced May 18, 2026
- EUDAMED 95cf9f42-5e98-4a6b-95d6-59de811dd220 61 fields · synced May 18, 2026
- EUDAMED 4ceda9a4-cf32-4db8-8731-3199e6624be6 61 fields · synced May 18, 2026
- EUDAMED a480b165-95c2-424c-aa0b-e4920ea57fa9 61 fields · synced May 18, 2026
- EUDAMED 973ab793-0d45-4b06-9b6e-8e47ee425183 61 fields · synced May 18, 2026
- EUDAMED fa294cbc-70a8-46ef-b2a1-edc1e9dcd71e 61 fields · synced May 18, 2026
- EUDAMED cc096821-c3d5-4675-8842-a31adb1e81ec 61 fields · synced May 18, 2026
- EUDAMED 3bbc906f-8403-4e59-9763-bada25b7d477 61 fields · synced May 19, 2026