Identity
- Trade Name
- IB Lab LAMA EUDAMED
- Device Name
- IB Lab LAMA EUDAMED
- Model / Reference
- V2.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120105730747 EUDAMED
- Basic UDI-DI
- 912010573IBLABLAMAPE EUDAMED
- Direct Marketing DI
- 09120105730747 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IB Lab LAMA by IB Lab GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223646 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 912010573IBLABLAMAPE | Class IIa | Active |
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Manufacturer
- Manufacturer
- IB Lab GmbH
- EUDAMED SRN
- AT-MF-000006554
Sources (2)
- EUDAMED 83c655c4-1cbf-43e4-8700-a3c0ea294029 61 fields · synced Jul 26, 2026
- FDA 510(k) K223646 1 fields · synced May 18, 2026