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AnyDANA
EUDAMEDClass IIb (EU MDR)
Ref SP-410Model AnyDANA-ARef SP-420Model AnyDANA-i
Identity
- Device Name
- AnyDANA EUDAMED
- Model / Reference
- AnyDANA-A EUDAMEDSP-410 EUDAMEDAnyDANA-i EUDAMEDSP-420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809220583506 EUDAMED08809220583513 EUDAMED
- Basic UDI-DI
- B-08809220583506 EUDAMEDB-08809220583513 EUDAMED
- EMDN Code
- Z12030392 INFUSION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- -1192 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AnyDANA 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-08809220583506 | 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 (2)
- EUDAMED a794902f-5d0d-4441-9427-224c3e9212ae 61 fields · synced Sep 17, 2026
- EUDAMED 62e43191-f912-4937-8b90-3ab7c3c96e20 61 fields · synced May 19, 2026