Identity
- Trade Name
- Reinforced Surgical Gown EUDAMED
- Device Name
- SMMMS non-woven surgeon’s gown – sterile EUDAMED
- Model / Reference
- LMS HCR L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932523031831 EUDAMED
- Basic UDI-DI
- 697170524Gowns05X5 EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Reinforced Surgical Gown by JiangSu MedPlus Non-Woven Manufacturer 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 | 697170524Gowns05X5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
- EUDAMED SRN
- CN-MF-000022548
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 00a971ee-05f7-4292-8b51-d1ac902a69a0 61 fields · synced Oct 5, 2026