Identity
- Device Name
- InAlyzer AIR EUDAMED
- Model / Reference
- InAlyzer_AIR Brochure EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800088200000 EUDAMED
- Basic UDI-DI
- B-08800088200000 EUDAMED
- EMDN Code
- Z11900103 X–RAY BONE DENSITOMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
InAlyzer AIR by Medikors Inc. — 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-08800088200000 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medikors Inc.
- EUDAMED SRN
- KR-MF-000026353
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 853da379-92e2-40c5-91d7-bd5111bf6ecf 61 fields · synced Jun 19, 2026