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impression tray
EUDAMEDClass I (EU MDR)
Ref 240757Model 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 EUDAMED240757 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429773680 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
impression tray by Across Industrial Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 06a71101-cdeb-4ea7-9eba-98913d4e48c1 61 fields · synced Jun 19, 2026