Identity
- Device Name
- Disposable sterile surgical gown EUDAMED
- Model / Reference
- KF-SG A01（EO） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976739564346 EUDAMED
- Basic UDI-DI
- 697673956KF-SGSQ EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Disposable sterile surgical gown by Guangdong Kingfa Sci. & Tech. 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 | 697673956KF-SGSQ | Class I | Active |
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Manufacturer
- Manufacturer
- Guangdong Kingfa Sci. & Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000009520
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 455b129f-8545-408a-ad3f-c13b3ab669f3 61 fields · synced Jun 19, 2026