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MDScope
EUDAMEDClass I (EU MDR)
Ref MS102-M002Model MS102(ELBP)-EURef MS102 Elite
Identity
- Trade Name
- MDScope EUDAMED
- Device Name
- Video Otoscope EUDAMED
- Model / Reference
- MS102(ELBP)-EU EUDAMEDMS102-M002 EUDAMEDMS102 Elite EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719884250413 EUDAMED04719884250406 EUDAMED
- Basic UDI-DI
- 471988425MS102GP EUDAMED
- EMDN Code
- Z12021009 DIRECT OUTPATIENT VIDEO-OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
MDScope by Apple Biomedical 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 | 471988425MS102GP | Class I | Active |
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Manufacturer
- Manufacturer
- Apple Biomedical Inc.
- EUDAMED SRN
- TW-MF-000038969
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e62cd174-3a85-4eb9-856a-749f114eaaa9 61 fields · synced Jul 25, 2026
- EUDAMED ca9215c6-fd6c-437d-8470-5bab06878bd0 61 fields · synced May 19, 2026