Identity
- Trade Name
- Surgical Gown EUDAMED
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- s EUDAMEDDS020001 EUDAMEDL EUDAMED2XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974589490122 EUDAMED06974589490092 EUDAMED06974589490115 EUDAMED06974589490078 EUDAMED
- Basic UDI-DI
- 697458949DS020001XQ EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Surgical Gown by Jiangsu Dingshun Medical 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 | 697458949DS020001XQ | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Dingshun Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000037429
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (4)
- EUDAMED 5dee688e-60d7-4bd1-913a-b7ebd74c9784 61 fields · synced Jul 14, 2026
- EUDAMED 51ca6c42-2aeb-4e79-8f5d-14b13cddc710 61 fields · synced Jul 9, 2026
- EUDAMED 9b9fd2c8-10b2-4711-9a5a-b00a1a2b9e93 61 fields · synced Jul 14, 2026
- EUDAMED 9a526774-135c-4425-a1d7-1475e18a5210 61 fields · synced Jul 14, 2026