Identity
- Trade Name
- Z12030385 EUDAMED
- Device Name
- Easy Release EUDAMED
- Model / Reference
- SU301 10box EUDAMEDSU302 10box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809220580536 EUDAMED
- Basic UDI-DI
- B-08809220580536 EUDAMED
- EMDN Code
- Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Z12030385 by Sooil Development Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809220580536 | Class IIa | Unknown |
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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 245f66fb-d720-4186-88f6-b3618f5b8350 61 fields · synced Jun 17, 2026