← Back to catalogue
Otoscope Set, PRIMA Classic, 2.5V WSB, Rechargeable Battery (Included), Chargin…
EUDAMEDClass I (EU MDR)
Ref 808-806-28
Identity
- Trade Name
- Otoscope Set, PRIMA Classic, 2.5V WSB, Rechargeable Battery (Included), Charging Station, Hard Case EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 808-806-28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102783623 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
Category: Otoscope, endoscopic
Otoscope Set, PRIMA Classic, 2.5V WSB, Rechargeable Battery (Included), Chargin… by Medical Devices (Pvt) Ltd — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Otoscope, endoscopic.
- PICCOLIGHT F.O. LED high power, otoscope, sky — Kirchner & Wilhelm GmbH + Co KG · Class I
- COMBILIGHT F.O.30 otoscope with charg. plug 240 V + accu 3.5 V — Kirchner & Wilhelm GmbH + Co KG · Class I
- Otoscope — Ecleris · Class I
- Otoscopes — Hangzhou Hawk Optical Electronic Instruments Co.,Ltd. · Class I
- Ear funnel, Ø 4.5 mm PU = 3 pcs. — Kirchner & Wilhelm GmbH + Co KG · Class I
- Reusable ear funnels, Ø 3.0 mm, 10 pcs. — Kirchner & Wilhelm GmbH + Co KG · Class I
- Otoscope — Jiangxi China Medical Equipment Co., Ltd · Class I
- EUROLIGHT F.O.30 otoscope with charg. plug 240 V + accu 3.5 V — Kirchner & Wilhelm GmbH + Co KG · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Devices (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000021845
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 4a3ccf64-6d65-4fe4-8cec-dd12cdc6d0fd 61 fields · synced Oct 7, 2026