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STRATOS (compact version)
EUDAMEDClass IIb (EU MDR)
Ref 7ZModel STRATOS
by Apelem
Identity
- Trade Name
- STRATOS (compact version) EUDAMED
- Device Name
- X-ray Bone densitometers EUDAMED
- Model / Reference
- STRATOS EUDAMED7Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760172650362 EUDAMED
- Basic UDI-DI
- 3760172657H5W7ZZ8 EUDAMED
- EMDN Code
- Z11900103 X–RAY BONE DENSITOMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
STRATOS (compact version) by Apelem — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3760172657H5W7ZZ8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Apelem
- EUDAMED SRN
- FR-MF-000008953
Sources (1)
- EUDAMED 87ee33a7-e443-4a09-8f02-ffa3c6dd055a 61 fields · synced Jul 8, 2026