Identity
- Device Name
- Micro-Screws (Titanium) EUDAMED
- Model / Reference
- 4015-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061644059416 EUDAMED
- Basic UDI-DI
- 4061644PG1401012Y EUDAMED
- EMDN Code
- P09120402 SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Bone nail end-cap
Micro-Screws (Titanium) by devemed GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone nail end-cap.
- Phantom® Fibula Nail System — Paragon 28 · Class II
- PTN PERITROCHANTERIC NAIL — Biomet Orthopedics, Inc. · Class II
- AJAX Nail — Auxein Medical Private Limited · Class II
- PEDIATRIC LOCKING NAIL SYSTEM — Biomet Orthopedics, Inc. · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- EXPert Nail — Synthes · Class II
- PTN PERITROCHANTERIC NAIL — Biomet Orthopedics, Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4061644PG1401012Y | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- devemed GmbH
- EUDAMED SRN
- DE-MF-000005568
Sources (1)
- EUDAMED 071a49a7-049e-40b7-80cb-3eb2a4a7c191 61 fields · synced Jun 19, 2026