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Standard Surgical Gowns
EUDAMEDClass I (EU MDR)
Ref ZLSG003Model S,M,L,XL,XXLRef ZLSG004Ref ZLSG002
Identity
- Trade Name
- STANDARD SURGICAL GOWNS EUDAMED
- Device Name
- STANDARD SURGICAL GOWNS EUDAMED
- Model / Reference
- S,M,L,XL,XXL EUDAMEDZLSG003 EUDAMEDZLSG004 EUDAMEDZLSG002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974742162033 EUDAMED06974742162040 EUDAMED06974742162026 EUDAMED
- Basic UDI-DI
- 697474216SSGSTG EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Standard Surgical Gowns by Farstar Medical Hubei 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 | 697474216SSGSTG | Class I | Active |
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Manufacturer
- Manufacturer
- Farstar Medical Hubei Ltd.
- EUDAMED SRN
- CN-MF-000017294
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED cb00e7af-8d5c-4319-86bf-ede7dceaa9f3 61 fields · synced Jul 21, 2026
- EUDAMED 1de2259e-0a3b-4764-89fd-db8fea20802d 61 fields · synced May 16, 2026
- EUDAMED d592a2a0-1154-4bdc-9e97-d71b9ce9341a 61 fields · synced May 18, 2026