Lobster Project 2.0
by Diametros Medical S.r.l. Unipersonale Italy EUDAMED
Ref LBT12, LBT14, LBS16, LBT10, LBT16, LBS08, LBS10, LBS14, LBT08Model Lobster Project 2.0
EMDN P09070305
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberITI 2290724 1 | Date9 Dec 2024 | StatusActive |
| European Union | CE/MDD | NumberB-08052107460098 | Date3 Mar 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- ITI 2290724 1 Issued
Technical documentation EU MDR
- Notified body
- TUV Rheinland Italia SRL 1936
- Issued
- 9 Dec 2024
- Expires
- 8 Dec 2029
Specification
- Model / Reference
- LBT12, LBT14, LBS16, LBT10, LBT16, LBS08, Lobster Project 2.0, LBS10, LBS14, LBT08
- Primary DI / UDI-DI
- 08052107460098, 08052107460104, 08052107460050, 08052107460081, 08052107460111, 08052107460012, 08052107460364, 08052107460401, 08052107460388, 08052107460333, 08052107460357, 08052107460371, 08052107460326
- Basic UDI-DI
- B-08052107460098, B-08052107460104, B-08052107460050, B-08052107460081, B-08052107460111, B-08052107460012, 80521074601LK
- EMDN Code
- P09070305 Spinal stabilisers, dynamic type
- Device Class
- Class IIbClass III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000013449
Other devices from Diametros Medical S.r.l. Unipersonale
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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
Sources (13)
- EUDAMED 5857d4f3-7cc7-49db-a14b-e3db3eada304
- EUDAMED 08052107460104|B-08052107460104
- EUDAMED 08052107460050|B-08052107460050
- EUDAMED 08052107460081|B-08052107460081
- EUDAMED 08052107460111|B-08052107460111
- EUDAMED 08052107460012|B-08052107460012
- EUDAMED 08052107460364|80521074601LK
- EUDAMED 08052107460401|80521074601LK
- EUDAMED 08052107460388|80521074601LK
- EUDAMED 08052107460333|80521074601LK
- EUDAMED 08052107460357|80521074601LK
- EUDAMED 08052107460371|80521074601LK
- EUDAMED 08052107460326|80521074601LK