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impression tray
EUDAMEDClass I (EU MDR)
Ref 240736Model 240701/240702/240703/240704/240705/240706/240707/240708/240709/240710/240711/240712/240713/240714/240715/240716/240717/240718/240719/240720/240721/240722/240723/240724/240725/240726/240727 etc
Identity
- Device Name
- impression tray EUDAMED
- Model / Reference
- 240701/240702/240703/240704/240705/240706/240707/240708/240709/240710/240711/240712/240713/240714/240715/240716/240717/240718/240719/240720/240721/240722/240723/240724/240725/240726/240727 etc EUDAMED240736 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429773475 EUDAMED
- Basic UDI-DI
- 697842977ZWIT4R EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 tray by Across Industrial 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 | 697842977ZWIT4R | Class I | Active |
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Manufacturer
- Manufacturer
- Across Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000047003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 54a070e9-d947-45af-8cd9-36ed0432a6f5 61 fields · synced Jun 18, 2026