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Base Camp Sheath System 90cm Berenstein
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref 5001-1-90B-EU510(k) K191717
Identity
- Trade Name
- Base Camp Sheath System 90cm Berenstein EUDAMED
- Device Name
- Base Camp Sheath System 90cm Berenstein EUDAMED
- Model / Reference
- 5001-1-90B-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853799007527 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
Base Camp Sheath System 90cm Berenstein by Route 92 Medical, Inc. — Class III — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191717 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 0853799007NSSEF | 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 (2)
- EUDAMED 59634947-df3d-436f-a66d-d1dc44b5262b 85 fields · synced Jun 18, 2026
- FDA 510(k) K191717 1 fields · synced May 18, 2026