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Ureterorenoscope
EUDAMEDClass IIa (EU MDR)
Ref 30-0640-00Model UreterorenoscopeRef 30-0395-00Ref 30-0405-02Ref 30-0682-00Ref 30-1027-00Ref 30-0070-02Ref 30-0528-00Ref 30-0405-00Ref 30-0406-02Ref 30-0069-02Ref 30-0407-00Ref 30-0514-60Ref 30-0407-60Ref 30-0069-01Ref 30-0403-03Ref 30-0632-00Ref 30-0774-00Ref 30-0514-03Ref 30-0403-00Ref 30-0070-00Ref 30-0642-00Ref 30-0684-60Ref 30-0395-02Ref 30-0886-00Ref 30-0070-01Ref 30-0514-09Ref 30-0514-00Ref 30-0552-09Ref 30-0683-60Ref 30-0558-02Ref 30-0406-00Ref 30-0558-60Ref 30-0528-02Ref 30-0395-09Ref 30-0844-00
Identity
- Trade Name
- Ureterorenoscope EUDAMED
- Device Name
- Rigid Endoscope EUDAMED
- Model / Reference
- Ureterorenoscope EUDAMED30-0640-00 EUDAMED30-0395-00 EUDAMED30-0405-02 EUDAMED30-0682-00 EUDAMED30-1027-00 EUDAMED30-0070-02 EUDAMED30-0528-00 EUDAMED30-0405-00 EUDAMED30-0406-02 EUDAMED30-0069-02 EUDAMED30-0407-00 EUDAMED30-0514-60 EUDAMED30-0407-60 EUDAMED30-0069-01 EUDAMED30-0403-03 EUDAMED30-0632-00 EUDAMED30-0774-00 EUDAMED30-0514-03 EUDAMED30-0403-00 EUDAMED30-0070-00 EUDAMED30-0642-00 EUDAMED30-0684-60 EUDAMED30-0395-02 EUDAMED30-0886-00 EUDAMED30-0070-01 EUDAMED30-0514-09 EUDAMED30-0514-00 EUDAMED30-0552-09 EUDAMED30-0683-60 EUDAMED30-0558-02 EUDAMED30-0406-00 EUDAMED30-0558-60 EUDAMED30-0528-02 EUDAMED30-0395-09 EUDAMED30-0844-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EINV300640001C EUDAMED+EINV300395001J EUDAMED+EINV300405021D EUDAMED+EINV300682001I EUDAMED+EINV301027001C EUDAMED+EINV300070021B EUDAMED+EINV300528001H EUDAMED+EINV300405001B EUDAMED+EINV300406021E EUDAMED+EINV300069021J EUDAMED+EINV300407001D EUDAMED+EINV300514601I EUDAMED+EINV300407601J EUDAMED+EINV300069011I EUDAMED+EINV300403031C EUDAMED+EINV300632001D EUDAMED+EINV300774001K EUDAMED+EINV300514031F EUDAMED+EINV3004030019 EUDAMED+EINV3000700019 EUDAMED+EINV300642001E EUDAMED+EINV300684601Q EUDAMED+EINV300395021L EUDAMED+EINV300886001O EUDAMED+EINV300070011A EUDAMED+EINV300514091L EUDAMED+EINV300514001C EUDAMED+EINV300552091N EUDAMED+EINV300683601P EUDAMED+EINV300558021M EUDAMED+EINV300406001C EUDAMED+EINV300558601Q EUDAMED+EINV300528021J EUDAMED+EINV300395091S EUDAMED+EINV300844001I EUDAMED
- Basic UDI-DI
- ++EINV30037112FL EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Flexible video ureteroscope, single-use
Ureterorenoscope by Innoview GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
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 | ++EINV30037112FL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innoview GmbH
- EUDAMED SRN
- DE-MF-000005567
Sources (35)
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