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CareVis BoluS
EUDAMEDClass IIb (EU MDR)
Ref S0006ERef M0008WRef S0005WRef S0008ERef S0006RRef M0008ERef M0010WRef S0010RRef S0010W
Identity
- Trade Name
- CareVis BoluS EUDAMED
- Device Name
- Single Use Infusion Pump EUDAMED
- Model / Reference
- S0006E EUDAMEDM0008W EUDAMEDS0005W EUDAMEDS0008E EUDAMEDS0006R EUDAMEDM0008E EUDAMEDM0010W EUDAMEDS0010R EUDAMEDS0010W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800027712175 EUDAMED08800027705184 EUDAMED08800027775149 EUDAMED08800027747115 EUDAMED08800027704385 EUDAMED08800027705153 EUDAMED08800027705245 EUDAMED08800027704262 EUDAMED08800027705306 EUDAMED
- Basic UDI-DI
- B-08800027712175 EUDAMEDB-08800027705184 EUDAMEDB-08800027775149 EUDAMEDB-08800027747115 EUDAMEDB-08800027704385 EUDAMEDB-08800027705153 EUDAMEDB-08800027705245 EUDAMEDB-08800027704262 EUDAMEDB-08800027705306 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
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
CareVis BoluS 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-08800027712175 | 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 (9)
- EUDAMED 6a4f9ff8-fdd2-4370-acfb-61fbd5f99bea 61 fields · synced Jul 30, 2026
- EUDAMED 3dcf7a87-8267-4364-80c3-31feab647976 61 fields · synced May 16, 2026
- EUDAMED 994b02d0-a9c4-414d-9fb2-ce24141f7dcc 61 fields · synced May 16, 2026
- EUDAMED c0ee2414-e168-4f29-9891-e1bdc170e31f 61 fields · synced May 16, 2026
- EUDAMED f38d4e41-d126-4c46-97e2-70e5a70c0152 61 fields · synced May 17, 2026
- EUDAMED 221c6f47-fe54-44cd-9647-d6dd04a86316 61 fields · synced May 17, 2026
- EUDAMED 533aa1e3-f5d3-4470-a0be-3b7e04bb9286 61 fields · synced May 17, 2026
- EUDAMED 9674991d-dc00-4b6c-8e4f-5877caa0119b 61 fields · synced May 17, 2026
- EUDAMED 69530632-20cc-448d-a776-c4210d70794e 61 fields · synced May 18, 2026