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Cystoscopic Instruments (Cystoscope)
EUDAMEDClass IIa (EU MDR)
Ref A0011Model /
Identity
- Device Name
- Cystoscopic Instruments (Cystoscope) EUDAMED
- Model / Reference
- / EUDAMEDA0011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945014205024 EUDAMED
- Basic UDI-DI
- 69450142Z120207C2C EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Cystoscopic Instruments (Cystoscope) by Zhejiang Tiansong Medical Instrument Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69450142Z120207C2C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Tiansong Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000008834
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fa916fc4-f4d0-4160-b7fc-58a8e56a083a 61 fields · synced Jul 10, 2026