Vipar Gown
by Arteks Ki̇mya Teksti̇l Sanayi̇i̇ Ve Ti̇caret Ltd. Şti̇. 16 variants
Ref ARGOWN-LHLModel ARGOWN-GK, ARGOWN-LH
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number86836493373ARGOWNGKZ5 | Date22 Dec 2022 | 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- Withdrawn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
- Device Name
- Vipar Gown-Disposable Surgical Birth GownVipar Gown-Disposable Laminated Pregnancy Surgical Gown
- Model / Reference
- ARGOWN-GK, ARGOWN-LHL, ARGOWN-LH
- Primary DI / UDI-DI
- 08684055792145, 08684055792176
- Basic UDI-DI
- 86836493373ARGOWNGKZ5, 86836493373ARGOWNLHZE
- EMDN Code
- T020401 Standard surgical gowns
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TR-MF-000030795
Other devices from Arteks Ki̇mya Teksti̇l Sanayi̇i̇ Ve Ti̇caret Ltd. Şti̇.
See all devices from Arteks Ki̇mya Teksti̇l Sanayi̇i̇ Ve Ti̇caret Ltd. Şti̇. →
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