Identity
- Trade Name
- Tenzing 7 EUDAMED
- Device Name
- Tenzing 7 Delivery Catheter EUDAMED
- Model / Reference
- 1005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853799007251 EUDAMED
- Basic UDI-DI
- 08537990076001VF EUDAMED
- EMDN Code
- C0104010202 CARDIAC ANGIOGRAPHY GUIDE CATHETERS EUDAMED
Classification
- Device Class
- Class III 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
Tenzing 7 by Route 92 Medical, Inc. — Class III — 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 | 08537990076001VF | Class III | Active |
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Manufacturer
- Manufacturer
- Route 92 Medical, Inc.
- EUDAMED SRN
- US-MF-000007441
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3df36d9a-315b-48d7-9e24-49df1802a5c4 61 fields · synced Jul 9, 2026