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Single-use HD Flexible Cystoscope
EUDAMEDClass IIa (EU MDR)
Ref SYV-H100Model SYV-H100、SYV-HA100Ref SYV-HA100
Identity
- Trade Name
- Single-use HD Flexible Cystoscope EUDAMED
- Device Name
- Single-use HD Flexible Cystoscope EUDAMED
- Model / Reference
- SYV-H100、SYV-HA100 EUDAMEDSYV-H100 EUDAMEDSYV-HA100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381254907 EUDAMED06971381254891 EUDAMED
- Basic UDI-DI
- 697138125028A8W EUDAMED
- Direct Marketing DI
- 06971381254907 EUDAMED06971381254891 EUDAMED
- EMDN Code
- Z12020701,Z12020713 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
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
Single-use HD Flexible Cystoscope by Scivita Medical Technology 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 | 697138125028A8W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8fb23dc6-16ae-4f61-9cbd-6cf56e2c6655 61 fields · synced Jul 24, 2026
- EUDAMED d8c8cb54-471b-42ad-ad84-be882a0a2ad5 61 fields · synced May 19, 2026