← Back to catalogue
Otoscopes
EUDAMEDClass I (EU MDR)
Ref T3060Model RJRef T0063Ref T1100Ref T3063Ref T1120
Identity
- Device Name
- Otoscopes EUDAMED
- Model / Reference
- RJ EUDAMEDT3060 EUDAMEDT0063 EUDAMEDT1100 EUDAMEDT3063 EUDAMEDT1120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014613090 EUDAMED06947014600861 EUDAMED06947014603077 EUDAMED06947014600830 EUDAMED06947014603084 EUDAMED
- Basic UDI-DI
- 69470146RJ00057410SW EUDAMED
- Direct Marketing DI
- 06947014613090 EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDAustria 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
Category: Otoscope, endoscopic
Otoscopes by Hangzhou Hawk Optical Electronic Instruments 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
- 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
- Otoscope Head, OMNI 3100 "C" Type, Cool Grey Color — 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 | 69470146RJ00057410SW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 0afb9443-8f26-46e0-8c97-a355dc33e682 61 fields · synced Jul 27, 2026
- EUDAMED 8f7a9a7a-747c-4cef-ac8b-e42225d98ab6 61 fields · synced Jun 14, 2026
- EUDAMED 9b442742-1bf0-4179-b444-2ea51638157c 61 fields · synced Jul 14, 2026
- EUDAMED f750d2f8-97bb-4993-a24d-13a9d598bec0 61 fields · synced Jul 15, 2026
- EUDAMED 733baf79-9881-4f68-b552-ccc9429dd6aa 61 fields · synced Jul 27, 2026