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DANA Diabecare RS
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref AS-120 5 kitsModel DANA Diabecare RS 5 kitsRef DANA Diabecare RS kitRef SP-120Model DANA Diabecare RS
Identity
- Device Name
- DANA Diabecare RS EUDAMED
- Model / Reference
- DANA Diabecare RS 5 kits EUDAMEDAS-120 5 kits EUDAMEDDANA Diabecare RS kit EUDAMEDDANA Diabecare RS EUDAMEDSP-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18809220584654 EUDAMED08809220582981 EUDAMED08809220582998 EUDAMED
- Basic UDI-DI
- B-18809220584654 EUDAMEDB-08809220582981 EUDAMEDB-08809220582998 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
DANA Diabecare RS by Sooil Development Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001604 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-18809220584654 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SOOIL Development Co., Ltd.
- EUDAMED SRN
- KR-MF-000008627
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED 6a7e8edc-1952-41cd-b2f0-4701c506428f 61 fields · synced Jul 31, 2026
- EUDAMED 45fef8b3-eae1-4ca7-86bb-2be3de9b07d2 61 fields · synced May 17, 2026
- EUDAMED 30eeba49-ab1a-4897-84ae-435b7bb21053 61 fields · synced May 18, 2026
- FDA 510(k) K001604 1 fields · synced May 18, 2026