Identity
- Trade Name
- Elabo EUDAMED
- Model / Reference
- YC-22-70 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809684739495 EUDAMED
- Basic UDI-DI
- B-08809684739495 EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Elabo by YURIM MEDICAL Co., Ltd. — Class IIa — 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-08809684739495 | Class IIa | Active |
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Manufacturer
- Manufacturer
- YURIM MEDICAL Co., Ltd.
- EUDAMED SRN
- KR-MF-000009011
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 8e2c00cb-28b0-4000-a25a-b9b772438506 61 fields · synced Jun 19, 2026