Identity
- Trade Name
- Surgical Gown EUDAMED
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- SGXXL EUDAMEDSG001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970863620162 EUDAMED
- Basic UDI-DI
- 697086362SGXXLVM EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 Gown by Bero(Qingyuan) Nonwovens 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 | 697086362SGXXLVM | Class I | Active |
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Manufacturer
- Manufacturer
- Bero(Qingyuan) Nonwovens Co.Ltd
- EUDAMED SRN
- CN-MF-000027685
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 7f74cd2c-57de-48f5-9863-eff3de2faa1f 61 fields · synced Jun 18, 2026