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OPERO gown SMMMS non-woven surgeon’s gown – reinforced, sterile
EUDAMEDClass I (EU MDR)
Ref W219100030_2080
Identity
- Trade Name
- OPERO gown SMMMS non-woven surgeon’s gown – reinforced, sterile EUDAMED
- Device Name
- SMMMS non-woven surgeon’s gown – sterile EUDAMED
- Model / Reference
- W219100030_2080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971705248292 EUDAMED
- Basic UDI-DI
- 697170524Gowns05X5 EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
OPERO gown SMMMS non-woven surgeon’s gown – reinforced, sterile by JiangSu MedPlus Non-Woven Manufacturer Co., Ltd — Class I — MDR — listed in EUDAMED
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 |
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Manufacturer
- Manufacturer
- Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
- EUDAMED SRN
- CN-MF-000022548
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 17728e54-3611-49c0-a895-c6d7a02f665c 61 fields · synced Oct 5, 2026