Identity
- Trade Name
- Barrier Film EUDAMED
- Device Name
- Disposable Barrier Sleeves/Covers/Film EUDAMED
- Model / Reference
- SD-4501、SD-4502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979999944302 EUDAMED
- Basic UDI-DI
- 697999994sleeve430B9 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER 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
Barrier Film by Snowdent Healthcare 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 | 697999994sleeve430B9 | Class I | Active |
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Manufacturer
- Manufacturer
- Snowdent Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000008775
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ad456343-2b19-41ad-8286-ca72c9b25a69 61 fields · synced Jul 10, 2026