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OPERO gown SMS non-woven surgeon's gown, sterile
EUDAMEDClass I (EU MDR)
Ref W216111180_0028
Identity
- Trade Name
- OPERO gown SMS non-woven surgeon's gown, sterile EUDAMED
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- W216111180_0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490856171 EUDAMED
- Basic UDI-DI
- 697349085UMSSGXZ 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 SMS non-woven surgeon's gown, 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 | 697349085UMSSGXZ | 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 483b8fec-72d6-471c-ad39-9e8b8d1963e0 61 fields · synced Oct 8, 2026