Gvacuum Pectus Excavatum Posture Correction Vacuum Bell White TP2
by Tedob Prodüksi̇yon Sağlik Ve Gida San. Ve Ti̇c. Ltd. Şti̇. 4 variants
Ref 190TP2, 125TP2, 140TP2Model PECTUSLAB GVACUUM
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 | Number8683318800GVPH | Date26 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- Withdrawn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
- Gvacuum Pectus Excavatum Posture Correction Vacuum Bell
- Model / Reference
- PECTUSLAB GVACUUM, 190TP2, 125TP2, 140TP2
- Primary DI / UDI-DI
- 08683318800108, 08683318800078, 08683318800085
- Basic UDI-DI
- 8683318800GVPH
- EMDN Code
- Y061219 Chest-lumb-sacral-hip-knee-ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000029627
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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