← Back to catalogue
OT8C otoscope
EUDAMEDClass I (EU MDR)
Ref /Ref 460E7810Ref 460E8810Ref 460-0010Ref 460-7810
Identity
- Trade Name
- OT8C otoscope EUDAMEDOT8C EUDAMED
- Device Name
- otoscope EUDAMED
- Model / Reference
- / EUDAMED460E7810 EUDAMED460E8810 EUDAMED460-0010 EUDAMED460-7810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095507260 EUDAMED06945095544388 EUDAMED06945095544494 EUDAMED06945095544142 EUDAMED06945095545149 EUDAMED
- Basic UDI-DI
- 69450955otoscopeTK EUDAMED
- Direct Marketing DI
- 06945095507260 EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMEDZ12149006 DIRECT OUTPATIENT 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
OT8C otoscope by Zumax Medical Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Otoscope, endoscopic.
- PICCOLIGHT F.O. LED high power, otoscope, sky — Kirchner & Wilhelm GmbH + Co KG · Class I
- Otoscope Set, OMNI 3000, Deluxe, LED, Black, Rechargeable — Medical Devices (Pvt) Ltd · 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
- Otoscope Set, VISIO 5, Classic F.O., 2.5V XENON — Medical Devices (Pvt) Ltd · 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
- Otoscope Set, OMNI 3000, Deluxe, Xenon, Blue — Medical Devices (Pvt) Ltd · 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 | 69450955otoscopeTK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zumax Medical CO., LTD.
- EUDAMED SRN
- CN-MF-000011126
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (5)
- EUDAMED d0b01633-5691-4c4e-bc78-dfe2febd8e21 61 fields · synced Oct 6, 2026
- EUDAMED d62b324e-848e-4ab9-8025-df71ebd253c5 61 fields · synced Jun 20, 2026
- EUDAMED f7b6c59a-719a-45dd-a8c1-0c036a14e3ed 61 fields · synced Jul 22, 2026
- EUDAMED 7e9b267c-f365-427d-b41c-85d5e6897b2b 61 fields · synced Jul 27, 2026
- EUDAMED 216e7ce0-ede8-4eff-8457-971bf50c05ec 61 fields · synced Jul 31, 2026