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Infusion Sets for single use with needles
EUDAMEDClass IIa (EU MDR)
Ref EXTModel RF,FS,IV,ST,EXT,WS,MP,SV
Identity
- Device Name
- Infusion Sets for single use with needles EUDAMED
- Model / Reference
- RF,FS,IV,ST,EXT,WS,MP,SV EUDAMEDEXT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976523541256 EUDAMED
- Basic UDI-DI
- 697652354SYQ001V7 EUDAMED
- EMDN Code
- A03010199 INFUSION CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Sets for single use with needles by Shandong Caremed Medical Products Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697652354SYQ001V7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Caremed Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000033413
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9194b4fb-b2cd-4cb6-9fa1-a0fbe71f8762 61 fields · synced Jun 18, 2026