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alginate impression material
EUDAMEDClass I (EU MDR)
Ref 250302Model 250301/250302/250303/250304/250305/250306/250307/ 250308/ 250309 /250310 /250311 /250312 /250313 /250314/ 250315/ 250316 /250317 /250318 /250319/ 250320Ref 250311Ref 250317Ref 250313Ref 250303Ref 250309Ref 250308Ref 250320Ref 250301Ref 250306Ref 250310
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 EUDAMED250302 EUDAMED250311 EUDAMED250317 EUDAMED250313 EUDAMED250303 EUDAMED250309 EUDAMED250308 EUDAMED250320 EUDAMED250301 EUDAMED250306 EUDAMED250310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429770016 EUDAMED06978429770108 EUDAMED06978429770160 EUDAMED06978429770122 EUDAMED06978429770023 EUDAMED06978429770085 EUDAMED06978429770078 EUDAMED06978429770191 EUDAMED06978429770009 EUDAMED06978429770054 EUDAMED06978429770092 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 (11)
- EUDAMED 45809466-dce2-49a8-8d85-f6f95ecf515a 61 fields · synced Oct 6, 2026
- EUDAMED 182c19ea-a2b3-47fb-ba8f-e9727e8dbd57 61 fields · synced May 11, 2026
- EUDAMED ef80d2f7-ca79-4341-8899-64b72d6b216c 61 fields · synced May 16, 2026
- EUDAMED f78738de-d1c3-4c6a-bdf2-2b9e0f93f766 61 fields · synced May 16, 2026
- EUDAMED dd420004-9560-4784-afba-770a846842b1 61 fields · synced May 16, 2026
- EUDAMED 98647f06-cf31-4c1d-9a93-a8d5c6758016 61 fields · synced May 17, 2026
- EUDAMED 3c16d1ac-842b-45e8-9d42-6cfc11f04662 61 fields · synced May 17, 2026
- EUDAMED 5c48fa84-4483-4183-9962-7be2356959a4 61 fields · synced May 17, 2026
- EUDAMED 983734c0-eb45-435e-a68d-e330035e43a7 61 fields · synced May 18, 2026
- EUDAMED 23c11ac8-28c1-428d-be70-b83c2eec4598 61 fields · synced May 18, 2026
- EUDAMED 5babc9aa-0062-4c11-b600-5fec1024e676 61 fields · synced May 19, 2026