Identity
- Device Name
- Surgical Gowns EUDAMED
- Model / Reference
- MF21031B1 EUDAMEDMF21033B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973178952010 EUDAMED
- Basic UDI-DI
- 697317895M01SP EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Surgical Gowns by Dongguan Shin Yi Healthcare Products Factory — 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 | 697317895M01SP | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Shin Yi Healthcare Products Factory
- EUDAMED SRN
- CN-MF-000020805
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED eef4f112-e5f0-4254-b496-4240353f3ddc 61 fields · synced May 23, 2026