Identity
- Trade Name
- EasyPath® RF Introducer Sheath EUDAMED
- Device Name
- EasyPath RF Introducer Sheath EUDAMED
- Model / Reference
- 10011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856571007265 EUDAMED
- Basic UDI-DI
- B-00856571007265 EUDAMED
- EMDN Code
- R0799 BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EasyPath® RF Introducer Sheath by Broncus Medical Inc. — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200702 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00856571007265 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Broncus Medical, Inc.
- EUDAMED SRN
- US-MF-000027543
- Authorised Representative
- MedDevConsult GmbH DE-AR-000005877
Sources (2)
- EUDAMED 5b79c151-faa2-4e7c-b642-2ec8bed59fda 61 fields · synced Jul 9, 2026
- FDA 510(k) K200702 1 fields · synced May 18, 2026