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Sterile Burette-type Infusion Sets for single use
EUDAMEDClass IIa (EU MDR)
Ref BS-100-GModel BS-50-G,BS-100-G,BS-150-GRef BS-50-GRef BS-150-G
Identity
- Device Name
- Sterile Burette-type Infusion Sets for single use EUDAMED
- Model / Reference
- BS-50-G,BS-100-G,BS-150-G EUDAMEDBS-100-G EUDAMEDBS-50-G EUDAMEDBS-150-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976523542321 EUDAMED06976523542324 EUDAMED06976523542317 EUDAMED16976523542314 EUDAMED16976523542338 EUDAMED
- Basic UDI-DI
- 697652354DSYQ0012X 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
Sterile Burette-type Infusion Sets for single use by Shandong Caremed Medical Products Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 697652354DSYQ0012X | 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 (5)
- EUDAMED 87fd8bea-61dd-4a61-9d85-fd52f4a4e733 61 fields · synced Oct 6, 2026
- EUDAMED 2bfc71a9-4164-4d88-af87-e6a938a2231a 61 fields · synced May 17, 2026
- EUDAMED a20de48f-621a-4755-870d-7ff5394112a9 61 fields · synced May 17, 2026
- EUDAMED 06cc88bf-17b2-4a11-bd22-134db80fc435 61 fields · synced May 19, 2026
- EUDAMED 914ea866-6d10-400b-84e7-29acae15f926 61 fields · synced May 19, 2026