Identity
- Device Name
- Surgical Gowns EUDAMED
- Model / Reference
- MF21051B1NS EUDAMEDMF21053B1NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973178952911 EUDAMED
- Basic UDI-DI
- 697317895M29TD EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS 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
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 | 697317895M29TD | 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 47b1d429-ebd1-4db2-a1dc-6f2be26209b3 61 fields · synced May 23, 2026