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ClearSheath
EUDAMEDClass IIa (EU MDR)
Ref NT/IS/LS/0745Model M -Type Femoral Sheath
Identity
- Trade Name
- ClearSheath EUDAMED
- Device Name
- Introducer Sheath with Dilator EUDAMED
- Model / Reference
- M -Type Femoral Sheath EUDAMEDNT/IS/LS/0745 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906194165452 EUDAMED
- Basic UDI-DI
- 890619416NTISQ2 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter introduction set, nonimplantable
ClearSheath by Newtech Medical Devices Pvt. Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 890619416NTISQ2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Newtech Medical Devices Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000045809
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED fca2ae25-c873-44c4-96b9-ede199663fe1 61 fields · synced Jun 18, 2026