← Back to catalogue
8F Base Camp System Berenstein 80cm
EUDAMEDClass III (EU MDR)
Ref 5001-2-80B-EU
Identity
- Trade Name
- 8F Base Camp System Berenstein 80cm EUDAMED
- Device Name
- Base Camp Sheath System 90cm Berenstein EUDAMED
- Model / Reference
- 5001-2-80B-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853799007862 EUDAMED
- Basic UDI-DI
- 0853799007NSSEF 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
8F Base Camp System Berenstein 80cm 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 | 0853799007NSSEF | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Route 92 Medical, Inc.
- EUDAMED SRN
- US-MF-000007441
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 823f91c7-0754-4d58-afe3-e3f1e29a5664 61 fields · synced Jul 29, 2026