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OPERO gown Spunlace non-woven surgeon's gown, sterile, standard
EUDAMEDClass I (EU MDR)
Ref W210111140_0028
Identity
- Trade Name
- OPERO gown Spunlace non-woven surgeon's gown, sterile, standard EUDAMED
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- W210111140_0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490857413 EUDAMED
- Basic UDI-DI
- 697349085UMSSGXZ EUDAMED
- EMDN Code
- T020401 STANDARD 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 Spunlace non-woven surgeon's gown, sterile, standard by Unimax Medical Products 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 | 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 8f81b3be-4955-4028-b27c-d0dc82bba3a8 61 fields · synced Oct 6, 2026