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ClearFold
EUDAMEDClass IIa (EU MDR)
Ref NT/MANC/2ONPHModel 2-Port Manifold and 3-Port Manifold
Identity
- Trade Name
- ClearFold EUDAMED
- Device Name
- Manifold EUDAMED
- Model / Reference
- 2-Port Manifold and 3-Port Manifold EUDAMEDNT/MANC/2ONPH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906194160365 EUDAMED
- Basic UDI-DI
- 890619416NTMANNS EUDAMED
- EMDN Code
- A0703 STOPCOCKS 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
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 (1)
- EUDAMED 4744a502-16ef-42b9-94f6-a76ce6d0f49a 61 fields · synced Jun 18, 2026