Identity
- Trade Name
- K NEEDLE EUDAMED
- Device Name
- K NEEDLE EUDAMED
- Model / Reference
- DRK-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850011935002 EUDAMED
- Basic UDI-DI
- B-00850011935002 EUDAMED
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Scalpel, single-use
K Needle by Lipocosm, Llc — Class IIa — 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-00850011935002 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lipocosm, Llc
- EUDAMED SRN
- US-MF-000002103
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c98dd9cd-21f5-4cdb-b5e6-86c367c5bbcf 61 fields · synced Jun 19, 2026