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CareVis PCA NaX
EUDAMEDClass IIb (EU MDR)
Ref X5030W-NRef M8001W-NRef G2003G-NRef L13006G-NRef G2005R-NRef M13005R-N
Identity
- Trade Name
- CareVis PCA NaX EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMED
- Model / Reference
- X5030W-N EUDAMEDM8001W-N EUDAMEDG2003G-N EUDAMEDL13006G-N EUDAMEDG2005R-N EUDAMEDM13005R-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027780778 EUDAMED08800331575343 EUDAMED08800332637446 EUDAMED08800332635879 EUDAMED08800331564460 EUDAMED08800331573745 EUDAMED
- Basic UDI-DI
- B-08800027780778 EUDAMEDB-08800331575343 EUDAMEDB-08800332637446 EUDAMEDB-08800332635879 EUDAMEDB-08800331564460 EUDAMEDB-08800331573745 EUDAMED
- EMDN Code
- A05010102 ELASTOMERIC SYSTEMS - FIXED FLOW WITH 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
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
CareVis PCA NaX by S&S Med Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08800027780778 | Class IIb | Active |
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Manufacturer
- Manufacturer
- S&S Med Co., Ltd.
- EUDAMED SRN
- KR-MF-000017308
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (6)
- EUDAMED 69e50d52-9d10-4120-998a-8b579ebea6cf 61 fields · synced Sep 30, 2026
- EUDAMED d118c795-cb6a-41a5-b075-f6ffbccfe068 61 fields · synced Sep 17, 2026
- EUDAMED 774e7325-8417-4012-8c19-330524940762 61 fields · synced Sep 17, 2026
- EUDAMED 31f04c69-3c52-4b71-9ef1-02e6be939db5 61 fields · synced Sep 17, 2026
- EUDAMED 4981299a-1970-4dd3-a697-997dae635211 61 fields · synced Sep 17, 2026
- EUDAMED 5e06a802-6b0e-4213-b64d-f4bf17cad3ef 61 fields · synced Sep 17, 2026