← Back to catalogue
OPERO gown SMS non-woven surgeon's gown, sterile
EUDAMEDClass I (EU MDR)
Ref W2121100050_0028Ref W216111140_0028Ref W216111170_0028Ref W215111140_0028Ref W215111160_0028Ref W216111130_0028Ref W215111170_0028Ref W2121100060_0028Ref W2131100050_0028Ref W2121100030_0028Ref W2131100060_0028Ref W216111150_0028Ref W2131100070_0028Ref W215111150_0028
Identity
- Trade Name
- OPERO gown SMS non-woven surgeon's gown, sterile EUDAMED
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- W2121100050_0028 EUDAMEDW216111140_0028 EUDAMEDW216111170_0028 EUDAMEDW215111140_0028 EUDAMEDW215111160_0028 EUDAMEDW216111130_0028 EUDAMEDW215111170_0028 EUDAMEDW2121100060_0028 EUDAMEDW2131100050_0028 EUDAMEDW2121100030_0028 EUDAMEDW2131100060_0028 EUDAMEDW216111150_0028 EUDAMEDW2131100070_0028 EUDAMEDW215111150_0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490859578 EUDAMED06973490856133 EUDAMED06973490856164 EUDAMED06973490856072 EUDAMED06973490856096 EUDAMED06973490856126 EUDAMED06973490856102 EUDAMED06973490859585 EUDAMED06973490859622 EUDAMED06973490859554 EUDAMED06973490859639 EUDAMED06973490856140 EUDAMED06973490859646 EUDAMED06973490856089 EUDAMED
- Basic UDI-DI
- 697349085UMSSGXZ EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMEDT020402 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (14)
- EUDAMED d548a049-9432-43ca-adcb-dc2ec24e0660 61 fields · synced Oct 6, 2026
- EUDAMED 0a35bb3d-3b3b-4913-add4-08a7006db29a 61 fields · synced May 16, 2026
- EUDAMED b2b8fc3a-5d3e-4920-9061-913d65ce136e 61 fields · synced May 17, 2026
- EUDAMED e80f8847-8ed1-4cd6-a685-c14cd6ad73b5 61 fields · synced May 17, 2026
- EUDAMED b3921e6d-cf2a-47b6-9a33-9683a6331785 61 fields · synced May 17, 2026
- EUDAMED 4154a062-533a-4018-8b72-bf06e9f348eb 61 fields · synced May 17, 2026
- EUDAMED 14fec629-1f43-47e5-ac7f-2fa81f27182d 61 fields · synced May 17, 2026
- EUDAMED c3255db7-8e7b-4d45-a56f-0136403d211a 61 fields · synced May 17, 2026
- EUDAMED 2d6c99cd-3499-48b8-86a0-5c52710e2a21 61 fields · synced May 17, 2026
- EUDAMED 615d7d11-5ea4-44c0-a4d0-2579f035ebe3 61 fields · synced May 18, 2026
- EUDAMED f57e8eb2-5d71-47be-97a9-2b6ca6d5aed5 61 fields · synced May 18, 2026
- EUDAMED 1829b6c7-b5f6-48d9-895b-4ce823b28ac2 61 fields · synced May 19, 2026
- EUDAMED 45013e96-d322-4fb5-ba92-503dd6b20984 61 fields · synced May 19, 2026
- EUDAMED 23d1bb1d-63a3-46b4-b450-1ebd31e24dee 61 fields · synced May 19, 2026