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Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.11, überlang
EUDAMEDClass IIb (EU MDR)
Ref 201329 uModel TrachealkanüleRef 201581 uRef 201571 uRef 201581Ref 200328 uRef 201591Ref 201329
Identity
- Trade Name
- Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.11, überlang EUDAMED
- Device Name
- Primedistom EUDAMED
- Model / Reference
- Trachealkanüle EUDAMED201329 u EUDAMED201581 u EUDAMED201571 u EUDAMED201581 EUDAMED200328 u EUDAMED201591 EUDAMED201329 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250203239868 EUDAMED04250203254700 EUDAMED04250203240086 EUDAMED04250203254687 EUDAMED04250203237031 EUDAMED04250203240284 EUDAMED04250203223898 EUDAMED
- Basic UDI-DI
- 42502032PRI06452 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
No
EUDAMEDEUDAMED
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: Tracheostomy tube, non-reinforced, non-customized, single-use
Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.11, überlang by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED
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Manufacturer's product page: PRIMEDISTOM® Trachealkanülen mit Cuff
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 | 42502032PRI06452 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Primed Halberstadt Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000004967
Sources (7)
- EUDAMED e8ddc06b-4042-4b18-ac54-002d2b2e9922 61 fields · synced Aug 4, 2026
- EUDAMED 58ee466d-2e55-43b1-858c-cfd6270a40ba 61 fields · synced May 17, 2026
- EUDAMED eb449892-6531-4ce7-92c2-ec3096eb6d8b 61 fields · synced May 17, 2026
- EUDAMED 582c51db-64be-4e9d-bab1-0bd7841a20e4 61 fields · synced May 17, 2026
- EUDAMED 554a9548-d7dc-472b-9342-68df7386edb8 61 fields · synced May 18, 2026
- EUDAMED b5fa66d8-1f45-43ff-9a7d-4aa9dae97453 61 fields · synced May 18, 2026
- EUDAMED c59d1010-bd4e-4b5c-8084-95ea5be22c5f 61 fields · synced May 18, 2026