MedTextile
by Medtex Swiss Ltd 330 variants
Ref 1017 - IModel 1017
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 | Number3800232484022RX 03800232484022 | Date12 May 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- Withdrawn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
- Cervical collar with trachea opening
- Model / Reference
- 1017, 1017 - I
- Primary DI / UDI-DI
- 03800232484022
- Basic UDI-DI
- 3800232484022RX
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.)
- Device Class
- Class I
- EU market of registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- BG-MF-000023453
Other devices from Medtex Swiss Ltd
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