OPERO Surgical clothing Non-woven surgical clothing set
by Mercator Medical Spółka Akcyjna 36 variants
Ref W312100060_5352
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
Non-woven surgical clothing set, non-sterile. This device is designed for use in various medical procedures and settings, providing a sterile environment while ensuring comfort and ease of use for the user.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5906615W31NSNWUC 05906615041405 | Date12 Mar 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- W312100060_5352
- Primary DI / UDI-DI
- 05906615041405
- Basic UDI-DI
- 5906615W31NSNWUC
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000018942
From the manufacturer
Manufacturer's product page: Single-use clothing
Other devices from Mercator Medical Spółka Akcyjna
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No