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Tubing Systems and Accessories for Fluid Delivery
EUDAMEDClass IIa (EU MDR)
Ref CL-H16002
Identity
- Trade Name
- Tubing Systems and Accessories for Fluid Delivery EUDAMED
- Device Name
- Tubing Systems and Accessories for Fluid Delivery EUDAMED
- Model / Reference
- CL-H16002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18586021470576 EUDAMED
- Basic UDI-DI
- 602147CLSET5L EUDAMED
- EMDN Code
- A03020102 HIGH PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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
Tubing Systems and Accessories for Fluid Delivery by Sky Medical a.s. — 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 | 602147CLSET5L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sky Medical a.s.
- EUDAMED SRN
- SK-MF-000001475
Sources (1)
- EUDAMED 63114e4a-fc49-49ef-bf0d-0c7a912601b4 61 fields · synced Oct 6, 2026