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MD Scope
EUDAMEDClass I (EU MDR)
Ref MS102(DXB)Model MS102(ELBP)-EURef MS102(DX3B)
Identity
- Trade Name
- MD Scope EUDAMED
- Device Name
- Video Otoscope EUDAMED
- Model / Reference
- MS102(ELBP)-EU EUDAMEDMS102(DXB) EUDAMEDMS102(DX3B) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719884250383 EUDAMED04719884250390 EUDAMED04719884250291 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
MD Scope 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 (3)
- EUDAMED 056f7859-6223-4cd0-b8bf-3b07c74a6e72 61 fields · synced Jul 16, 2026
- EUDAMED c7c9bd0d-8ff6-4700-a5e5-1de022646730 61 fields · synced May 17, 2026
- EUDAMED 38b14124-3df9-42d8-9142-c5dc9c7c3739 61 fields · synced May 19, 2026