Identity
- Trade Name
- KEISEI Micro Needle Holders 15cm curved EUDAMED
- Device Name
- KEISEI Micro Needle Holders 15cm curved EUDAMED
- Model / Reference
- NH-158CR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 34946279255048 EUDAMED
- Basic UDI-DI
- B-34946279255048 EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Suturing needle holder, reusable
KEISEI Micro Needle Holders 15cm curved by Keisei Medical Industrial Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-34946279255048 | Class I | Active |
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Manufacturer
- Manufacturer
- Keisei Medical Industrial Co., Ltd.
- EUDAMED SRN
- JP-MF-000021775
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 16deb329-aa41-4dd7-9b0d-d5b996ff2ab9 61 fields · synced Jun 18, 2026