Identity
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- G1011 EUDAMEDn/a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974960066014 EUDAMED
- Basic UDI-DI
- 697496006G1011B3 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Isolation Gown by Xiantao S&J Protective Products 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 | 697496006G1011B3 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao S&J Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000009006
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 99ad7eeb-4ea0-4a47-9dfd-6921a7c1d505 61 fields · synced Jul 10, 2026