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alginate impression material
EUDAMEDClass I (EU MDR)
Ref 250319Model 250301/250302/250303/250304/250305/250306/250307/ 250308/ 250309 /250310 /250311 /250312 /250313 /250314/ 250315/ 250316 /250317 /250318 /250319/ 250320
Identity
- Device Name
- alginate impression material EUDAMED
- Model / Reference
- 250301/250302/250303/250304/250305/250306/250307/ 250308/ 250309 /250310 /250311 /250312 /250313 /250314/ 250315/ 250316 /250317 /250318 /250319/ 250320 EUDAMED250319 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429770184 EUDAMED
- Basic UDI-DI
- 697842977ZWAIM63 EUDAMED
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
alginate impression material 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 | 697842977ZWAIM63 | 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 d15d94b3-5b5d-4161-86fb-295c2d8cc8f6 61 fields · synced Jun 19, 2026