Barotech
by Barotek Tibbi Malzeme Medikal Urunler Sualti Dalis Ekipmanlari San. Ve Tic. Ltd. Sti. Türkiye EUDAMED
Ref TET-12, OMG-10, OMG-8, DEC-12, OMG-6, DEC-16, OMG-4, OMG-16, MON, DEC-4Model TETRAKTİS 12, MULTİ 10, MULTİ 8, MULTİ DK 1700, MULTİ 6, MULTİ DK 1800, MULTİ 4, MULTİ 16, MONO, MULTİ DK 1500
EMDN Z120308
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08699303310248 | Date9 Dec 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Hyperbaric Oxygen Treatment Chamber SystemHyperbaric Oxygen Treatment SystemsHyperbaric Oxygen Therapy Systems
- Model / Reference
- TETRAKTİS 12, TET-12, MULTİ 10, OMG-10, MULTİ 8, OMG-8, MULTİ DK 1700, DEC-12, MULTİ 6, OMG-6, MULTİ DK 1800, DEC-16, MULTİ 4, OMG-4, MULTİ 16, OMG-16, MONO, MON, MULTİ DK 1500, DEC-4
- Primary DI / UDI-DI
- 08699303310248, 08699303310132, 08699303310125, 08699303310026, 08699303310118, 08699303310033, 08699303310101, 08699303310163, 08699303310309, 08699303310002
- Basic UDI-DI
- B-08699303310248, B-08699303310132, B-08699303310125, B-08699303310026, B-08699303310118, B-08699303310033, B-08699303310101, B-08699303310163, B-08699303310309, B-08699303310002
- EMDN Code
- Z120308 Hyperbaric chambers
- Device Class
- Class IIb
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000042523
Other devices from Barotek Tibbi Malzeme Medikal Urunler Sualti Dalis Ekipmanlari San. Ve Tic. Ltd. Sti.
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (10)
- EUDAMED fe18ddad-dfba-4db6-aadf-8aa8e5ebc152
- EUDAMED 08699303310132|B-08699303310132
- EUDAMED 08699303310125|B-08699303310125
- EUDAMED 08699303310026|B-08699303310026
- EUDAMED 08699303310118|B-08699303310118
- EUDAMED 08699303310033|B-08699303310033
- EUDAMED 08699303310101|B-08699303310101
- EUDAMED 08699303310163|B-08699303310163
- EUDAMED 08699303310309|B-08699303310309
- EUDAMED 08699303310002|B-08699303310002