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Chemfort Catheter Adaptor
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref MG245591Model Chemfort
Identity
- Trade Name
- Chemfort Catheter Adaptor EUDAMED
- Device Name
- Chemfort (Closed System Transfer Device) EUDAMED
- Model / Reference
- Chemfort EUDAMEDMG245591 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290115925910 EUDAMED
- Basic UDI-DI
- 729011592ChemfortC7 EUDAMED
- Unit of Use DI
- 27290115925917 EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Chemfort Catheter Adaptor by Simplivia Healthcare Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231286 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 729011592ChemfortC7 | Class I | Active |
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Manufacturer
- Manufacturer
- Simplivia Healthcare Ltd.
- EUDAMED SRN
- IL-MF-000035592
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (2)
- EUDAMED ed5bea2b-0be9-4ebc-859b-f43ac8432918 61 fields · synced Jul 10, 2026
- FDA 510(k) K231286 1 fields · synced May 18, 2026