← Back to catalogue
Trachealkanüle Optima Voice Standard Gr.9, dehp-frei
EUDAMEDClass IIb (EU MDR)
Ref 102036Model Trachealkanüle
Identity
- Trade Name
- Trachealkanüle Optima Voice Standard Gr.9, dehp-frei EUDAMED
- Device Name
- Optima, Ultrasoft, ProLine EUDAMED
- Model / Reference
- Trachealkanüle EUDAMED102036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250203214810 EUDAMED
- Basic UDI-DI
- 42502032PRI0624W EUDAMED
- EMDN Code
- R0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb 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
Trachealkanüle Optima Voice Standard Gr.9, dehp-frei by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED
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 | 42502032PRI0624W | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Primed Halberstadt Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000004967
Sources (1)
- EUDAMED e27d6288-6552-4211-a9d8-6413caba2488 61 fields · synced Jul 10, 2026