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Ce_nl-Be Stratus 2_mdr
EUDAMEDClass I (EU MDR)
Ref FGSS-1213Model Digital talking book
Identity
- Trade Name
- CE_NL-BE STRATUS 2_MDR EUDAMED
- Device Name
- Digital talking book EUDAMED
- Model / Reference
- Digital talking book EUDAMEDFGSS-1213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18306110001340 EUDAMED
- Basic UDI-DI
- 83061100002JB EUDAMED
- EMDN Code
- Y212703 PAGE-TURNERS EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ce_nl-Be Stratus 2_mdr by Technologies HumanWare Inc. — Class I — 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 | 83061100002JB | Class I | Active |
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Manufacturer
- Manufacturer
- Technologies HumanWare Inc.
- EUDAMED SRN
- CA-MF-000022852
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED dd841960-5d35-4149-9ec5-ea2347a289cf 61 fields · synced Jun 19, 2026