Identity
- Trade Name
- BIP O-Twist-Marker S Marking Clip EUDAMED
- Device Name
- Marking Clip EUDAMED
- Model / Reference
- OTM3.0S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251135805176 EUDAMED
- Basic UDI-DI
- 42511358000006DW EUDAMED
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
BIP O-Twist-Marker S Marking Clip by BIP Biomedizinische Instrumente und Produkte GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 42511358000006DW | Class IIb | Active |
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Manufacturer
- Manufacturer
- BIP Biomedizinische Instrumente und Produkte GmbH
- EUDAMED SRN
- DE-MF-000010311
Sources (1)
- EUDAMED 51887f3a-def2-4a49-a106-0dc6ed62a3aa 61 fields · synced Oct 7, 2026