← Back to catalogue
CareVis VariO TwiN NaX
EUDAMEDClass IIb (EU MDR)
Ref VM13-TNRef VX13-TNRef VM26-TRef VL26-TNRef VX0535-T
Identity
- Trade Name
- CareVis VariO TwiN NaX EUDAMEDCareVis VariO TwiN EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMED
- Model / Reference
- VM13-TN EUDAMEDVX13-TN EUDAMEDVM26-T EUDAMEDVL26-TN EUDAMEDVX0535-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027785896 EUDAMED08800027786060 EUDAMED08800331568963 EUDAMED08800027786039 EUDAMED08800027787357 EUDAMED
- Basic UDI-DI
- B-08800027785896 EUDAMEDB-08800027786060 EUDAMEDB-08800331568963 EUDAMEDB-08800027786039 EUDAMEDB-08800027787357 EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Elastomeric infusion pump system
CareVis VariO TwiN NaX by S&S Med Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Elastomeric infusion pump system.
- SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h — Epic International (Thailand) Co., Ltd. · Class IIa
- Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
- SMARTeZ RS-General Infusion 250-500-30m with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- Halyard — Avanos Medical, Inc. · Class II
- SMARTeZ RS-PainBloc-Fixed Flow Rate 120-5-24h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ Pump 500-40-12.5h — Epic International (Thailand) Co., Ltd. · Class IIa
- Halyard — Avanos Medical, Inc. · Class II
- SMARTeZ RS-PainBloc-Fixed Flow Rate 80-5-16h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800027785896 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S&S Med Co., Ltd.
- EUDAMED SRN
- KR-MF-000017308
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (5)
- EUDAMED 5afa51dc-e369-4708-b1df-3556ab93d3ec 61 fields · synced Sep 18, 2026
- EUDAMED 4d246fdf-c5e6-4663-b863-27e524e97a86 61 fields · synced May 16, 2026
- EUDAMED 4d12cfc1-5c86-452d-93e7-3b63b62f3f75 61 fields · synced May 17, 2026
- EUDAMED 3aee117d-195d-4dc2-b3fd-39dced6cb7ec 61 fields · synced May 17, 2026
- EUDAMED 4330e3fb-47a2-4a79-a7ea-ccade3d801d3 61 fields · synced May 18, 2026