← Back to catalogue
ClearSheath
EUDAMEDClass IIa (EU MDR)
Ref NT/IS/RSM/0607Model M -Type Femoral Sheath
Identity
- Trade Name
- ClearSheath EUDAMED
- Device Name
- Introducer Sheath with Dilator EUDAMED
- Model / Reference
- M -Type Femoral Sheath EUDAMEDNT/IS/RSM/0607 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906194163489 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
ClearSheath by Newtech Medical Devices Pvt. Ltd. — Class IIa — 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 | 890619416NTISQ2 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newtech Medical Devices Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000045809
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 4272ff36-00d0-4ad4-a3b9-f9a7cf426ea3 61 fields · synced Jun 18, 2026