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Tubing Systems and Accessories for Fluid Delivery
EUDAMEDClass IIa (EU MDR)
Ref TS-M10038
Identity
- Trade Name
- Tubing Systems and Accessories for Fluid Delivery EUDAMED
- Device Name
- Tubing Systems and Accessories for Fluid Delivery EUDAMED
- Model / Reference
- TS-M10038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18586026080428 EUDAMED
- Basic UDI-DI
- 602147TSSETCY EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tubing Systems and Accessories for Fluid Delivery by Sky Medical a.s. — Class IIa — CE/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 | 602147TSSETCY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sky Medical a.s.
- EUDAMED SRN
- SK-MF-000001475
Sources (1)
- EUDAMED 96fdafb5-49f8-461b-84c5-3cd1fdd0d90f 61 fields · synced Oct 7, 2026