Identity
- Trade Name
- Safe&Sound Finger Bandage and Applicator EUDAMED
- Device Name
- SAFE&SOUND elastic bandages EUDAMED
- Model / Reference
- SA8317 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864853614 EUDAMED
- Basic UDI-DI
- 697386485SAFESOUND013X EUDAMED
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Safe&Sound Finger Bandage and Applicator by Suzhou Sunmed 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 | 697386485SAFESOUND013X | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1a2680fb-cd5c-499b-a8e2-f410c919e058 61 fields · synced Oct 6, 2026