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CareVis PCA
EUDAMEDClass IIb (EU MDR)
Ref L2060WRef L5060ERef M1006ERef S0506ERef S0506RRef M2060ERef S4001WRef L8030WRef M1030ERef X4005W
Identity
- Trade Name
- CareVis PCA EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMED
- Model / Reference
- L2060W EUDAMEDL5060E EUDAMEDM1006E EUDAMEDS0506E EUDAMEDS0506R EUDAMEDM2060E EUDAMEDS4001W EUDAMEDL8030W EUDAMEDM1030E EUDAMEDX4005W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027744206 EUDAMED08800027711659 EUDAMED08800027737345 EUDAMED08800027734979 EUDAMED08800027734283 EUDAMED08800027732661 EUDAMED08800331532971 EUDAMED08800027744114 EUDAMED08800027711710 EUDAMED08800332610128 EUDAMED
- Basic UDI-DI
- B-08800027744206 EUDAMEDB-08800027711659 EUDAMEDB-08800027737345 EUDAMEDB-08800027734979 EUDAMEDB-08800027734283 EUDAMEDB-08800027732661 EUDAMEDB-08800331532971 EUDAMEDB-08800027744114 EUDAMEDB-08800027711710 EUDAMEDB-08800332610128 EUDAMED
- EMDN Code
- A05010102 ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS EUDAMEDA05010101 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
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 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-08800027744206 | 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 (10)
- EUDAMED 80d42e7d-5ad9-48ff-9d35-d0b0504d0abc 61 fields · synced Sep 30, 2026
- EUDAMED 5fe52184-d6e4-426f-b7eb-86431d563270 61 fields · synced May 17, 2026
- EUDAMED 9200ede2-c8fe-4270-9429-82477d6902e1 61 fields · synced May 18, 2026
- EUDAMED 4e0e5473-9ae2-4f60-ac4a-ab0b17cc1deb 61 fields · synced May 18, 2026
- EUDAMED 091dab0b-d5e1-49fc-a4f4-82acb062f1ba 61 fields · synced May 18, 2026
- EUDAMED 39573439-3e91-4576-8989-bade5de87171 61 fields · synced May 18, 2026
- EUDAMED 607f9605-6081-4a2d-b48d-1940708094fa 61 fields · synced Sep 17, 2026
- EUDAMED bc261ea6-38e9-44dc-a3f6-21b80eaad108 61 fields · synced Sep 17, 2026
- EUDAMED 26958099-a3c1-451c-8fe1-d2837580c5db 61 fields · synced Sep 17, 2026
- EUDAMED 113f925c-da4b-4625-b4ed-06d9ffeaeb4c 61 fields · synced Sep 17, 2026