Identity
- Trade Name
- FA001 No.1 ambulance dressings EUDAMED
- Device Name
- AMBULANCE DRESSING STERILE EUDAMED
- Model / Reference
- FA001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864855281 EUDAMED
- Basic UDI-DI
- 697386485DMBANFB3R EUDAMED
- Direct Marketing DI
- 06973864855281 EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
FA001 No.1 ambulance dressings 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 | 697386485DMBANFB3R | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 948ec71f-3712-4283-ab62-6281faf444a4 61 fields · synced Jun 19, 2026