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ClearFold
EUDAMEDClass IIa (EU MDR)
Ref NT/MAN/2ONPHModel 2-Port Manifold and 3-Port ManifoldRef NT/MANC/2OFFPRef NT/MAN/3OFFPHRef NT/MAN/2OFFPRef NT/MANC/3ONPRef NT/MANC/2ONPRef NT/MAN/3ONPHRef NT/MAN/2ONP Ref NT/MANC/3OFFPHRef NT/MANC/3OFFP
Identity
- Trade Name
- ClearFold EUDAMED
- Device Name
- Manifold EUDAMED
- Model / Reference
- 2-Port Manifold and 3-Port Manifold EUDAMEDNT/MAN/2ONPH EUDAMEDNT/MANC/2OFFP EUDAMEDNT/MAN/3OFFPH EUDAMEDNT/MAN/2OFFP EUDAMEDNT/MANC/3ONP EUDAMEDNT/MANC/2ONP EUDAMEDNT/MAN/3ONPH EUDAMEDNT/MAN/2ONP EUDAMEDNT/MANC/3OFFPH EUDAMEDNT/MANC/3OFFP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906194160310 EUDAMED08906194160051 EUDAMED08906194160358 EUDAMED08906194160327 EUDAMED08906194160068 EUDAMED08906194160044 EUDAMED08906194160341 EUDAMED08906194160303 EUDAMED08906194160402 EUDAMED08906194160075 EUDAMED
- Basic UDI-DI
- 890619416NTMANNS EUDAMED
- EMDN Code
- A0703 STOPCOCKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
ClearFold 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 | 890619416NTMANNS | 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 (10)
- EUDAMED b76cc58f-dffc-4263-ba50-e89827778e94 61 fields · synced Aug 4, 2026
- EUDAMED 387b7da7-ab5f-4cc4-a626-e651cb3c2fff 61 fields · synced May 17, 2026
- EUDAMED 3409dd21-e3e3-4516-94ca-422ba611c220 61 fields · synced May 17, 2026
- EUDAMED 122b9755-51af-4cda-ad64-a90b063faddb 61 fields · synced May 17, 2026
- EUDAMED b668b544-0049-428b-8c2c-8a39ebc2418b 61 fields · synced May 17, 2026
- EUDAMED 4d644bb3-be85-4568-aa5c-e735fb6b172c 61 fields · synced May 17, 2026
- EUDAMED 60497bfb-10c9-4111-984f-909cbd530612 61 fields · synced May 18, 2026
- EUDAMED 7af85a12-2701-4ee4-9217-72cd09bfdebf 61 fields · synced May 18, 2026
- EUDAMED d0065e2d-e8c4-42ea-a8a9-061d69338fa8 61 fields · synced May 18, 2026
- EUDAMED 0d870ae6-7908-4f5a-ac50-ee56090f1a76 61 fields · synced May 18, 2026