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HiPoint 88 reperfusion catheter with Tenzing 8
EUDAMEDClass III (EU MDR)
Ref 2004-88-143R-EU
Identity
- Trade Name
- HiPoint 88 reperfusion catheter with Tenzing 8 EUDAMED
- Device Name
- HiPoint 70 reperfusion catheter with Tenzing 7 EUDAMED
- Model / Reference
- 2004-88-143R-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853799007305 EUDAMED
- Basic UDI-DI
- 0853799007NRSEC EUDAMED
- EMDN Code
- C010401020501 MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS 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
HiPoint 88 reperfusion catheter with Tenzing 8 by Route 92 Medical, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: HiPoint® Reperfusion System
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 | 0853799007NRSEC | 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 efeb38eb-c1ff-4683-9cb5-9065584e1fa1 61 fields · synced Oct 6, 2026