Stealth Belt®
by Stealth Belt, Inc. 46 variants
Ref PR24-30LT134BLK-VR
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 | Number506091772AA003M 05060917725606 | Date7 Nov 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- Withdrawn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
- Stealth Belt®
- Model / Reference
- PR24-30LT134BLK-VR
- Primary DI / UDI-DI
- 05060917725606
- Basic UDI-DI
- 506091772AA003M
- EMDN Code
- A108006 Abdominal ostomy support belts
- Device Class
- Class I
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000028364
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Stealth Belt, Inc.
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