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DANA Auto Setter
EUDAMEDClass IIb (EU MDR)
Ref SP-390Model DANA Auto Setter Dual
Identity
- Device Name
- DANA Auto Setter EUDAMED
- Model / Reference
- DANA Auto Setter Dual EUDAMEDSP-390 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809220582929 EUDAMED
- Basic UDI-DI
- B-08809220582929 EUDAMED
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES 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
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DANA Auto Setter by Sooil Development 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-08809220582929 | 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 (1)
- EUDAMED 70c369e0-5347-4b80-ad84-f58440c1176c 61 fields · synced Jul 11, 2026