Identity
- Trade Name
- Jansen Doppellöffel, 160mm EUDAMED
- Device Name
- Schaber , Küretten - Curettes EUDAMED
- Model / Reference
- TAFK8033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14260526215651 EUDAMED
- Basic UDI-DI
- 426052621SIFK013K EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER 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
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: General internal orthopaedic fixation system implantation kit
Jansen Doppellöffel, 160mm by Scholz Medical GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · 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 | 426052621SIFK013K | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scholz Medical GmbH
- EUDAMED SRN
- DE-MF-000008955
Sources (1)
- EUDAMED e4932e01-7a9d-4452-9abc-d1358b94afde 61 fields · synced Jun 19, 2026