Identity
- Device Name
- Sterile surgical gown EUDAMED
- Model / Reference
- / EUDAMEDPM5101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974767555100 EUDAMED
- Basic UDI-DI
- 69747675501G010166 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I 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
Sterile surgical gown by Jiangyin PureMED 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 | 69747675501G010166 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangyin PureMED Products Co., LTD
- EUDAMED SRN
- CN-MF-000028858
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 1f0d06c6-72d5-4413-b5cb-4ec3b8c98af6 61 fields · synced Jun 20, 2026