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OPERO gown SMS non-woven surgeon's gown, non -sterile
EUDAMEDClass I (EU MDR)
Ref W2221100060_0028
Identity
- Trade Name
- OPERO gown SMS non-woven surgeon's gown, non -sterile EUDAMED
- Device Name
- Non-woven surgeon's gown, non -sterile EUDAMED
- Model / Reference
- W2221100060_0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490859684 EUDAMED
- Basic UDI-DI
- 697349085UMNSSG57 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
OPERO gown SMS non-woven surgeon's gown, non -sterile by Unimax 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 | 697349085UMNSSG57 | Class I | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3b38e07e-0966-4266-977a-24097949be9c 61 fields · synced Jun 19, 2026