Identity
- Trade Name
- Introducer Sheath Sets EUDAMED
- Device Name
- Introducer Sheath Sets EUDAMED
- Model / Reference
- T5F16P25L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958481488234 EUDAMED
- Basic UDI-DI
- 695848140077MS EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Introducer Sheath Sets (including Introducer Sheaths, Dilators, Guide Wires, Introducer Needles, Scalpels, and Syringes) EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Vascular catheter introduction set, nonimplantable
Introducer Sheath Sets by BrosMed Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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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 | 695848140077MS | Class IIa | Active |
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Manufacturer
- Manufacturer
- BrosMed Medical
- EUDAMED SRN
- CN-PR-000048143
Sources (1)
- EUDAMED dbac7023-362c-4fe7-bbea-97490f007eec 61 fields · synced Jun 19, 2026