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OssaBase-HA
EUDAMEDClass IIb (EU MDR)
Ref 42:6Model OssaBase-HA
by LASAK s.r.o.
Identity
- Trade Name
- OssaBase-HA EUDAMED
- Device Name
- OssaBase-HA EUDAMED
- Model / Reference
- OssaBase-HA EUDAMED42:6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573022082 EUDAMED
- Basic UDI-DI
- B-08595573022082 EUDAMED
- EMDN Code
- P900403 NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OssaBase-HA by LASAK s.r.o. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08595573022082 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED fe14a829-85ae-44c9-bbf6-092652f28b0b 61 fields · synced Jun 18, 2026