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Otoscope Set, PRIMA Operating, 2.5V WSB, Rechargeable Battery (Included), Hard …
EUDAMEDClass I (EU MDR)
Ref 808-824-27
Identity
- Trade Name
- Otoscope Set, PRIMA Operating, 2.5V WSB, Rechargeable Battery (Included), Hard Case EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 808-824-27 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102783654 EUDAMED
- Basic UDI-DI
- 896110278OTOS808XP EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Otoscope Set, PRIMA Operating, 2.5V WSB, Rechargeable Battery (Included), Hard … by Medical Devices (Pvt) Ltd — Class I — MDR — listed in EUDAMED
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 | 896110278OTOS808XP | Class I | Active |
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Manufacturer
- Manufacturer
- Medical Devices (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000021845
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9674cb5f-ffed-4143-be7f-a707b3a625e2 61 fields · synced Jul 28, 2026