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SP SensaCath Flex Compact IC, CH14
EUDAMEDClass IIa (EU MDR)
Ref SPPSCXC14Model NCR10M
Identity
- Trade Name
- SP SensaCath Flex Compact IC, CH14 EUDAMED
- Device Name
- Sterile urethral catheter for single use EUDAMED
- Model / Reference
- NCR10M EUDAMEDSPPSCXC14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100039560 EUDAMED
- Basic UDI-DI
- 697262497SUCSUWY EUDAMED
- Direct Marketing DI
- 05036100039560 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
SP SensaCath Flex Compact IC, CH14 by Hangzhou Jimushi Meditech 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 | 697262497SUCSUWY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Jimushi Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000033832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8893a0bf-0e5f-4d20-8c01-a7e2087ecc2b 61 fields · synced Jun 18, 2026