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Enraf
EUDAMEDClass I (EU MDR)
Ref WPC-3444112Ref OTH-3444180Ref STR-3444072Ref WPC-3444211Ref STR-3444071Ref WPC-3444673
Identity
- Trade Name
- Enraf EUDAMED
- Device Name
- Medical Wire EUDAMEDMedical Device Accessory EUDAMEDMedical Straps EUDAMED
- Model / Reference
- WPC-3444112 EUDAMEDOTH-3444180 EUDAMEDSTR-3444072 EUDAMEDWPC-3444211 EUDAMEDSTR-3444071 EUDAMEDWPC-3444673 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872333562 EUDAMED04719872333548 EUDAMED04719872332794 EUDAMED04719872333531 EUDAMED04719872332787 EUDAMED04719872333517 EUDAMED
- Basic UDI-DI
- 471987233WPCS3 EUDAMED471987233OTHRH EUDAMED471987233STRSR EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Enraf by ZMI Electronics Ltd. — Class I — 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 | 471987233WPCS3 | Class I | Active |
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Manufacturer
- Manufacturer
- ZMI Electronics Ltd.
- EUDAMED SRN
- TW-MF-000003571
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (6)
- EUDAMED aa00573d-e7c1-4943-a5cb-f1854c1e34be 61 fields · synced Jul 27, 2026
- EUDAMED cf4ef339-1068-489b-8b70-3ba126c14db2 61 fields · synced May 11, 2026
- EUDAMED 707a1fa7-e4d4-49f0-946b-127638e06def 61 fields · synced May 16, 2026
- EUDAMED 044e1b6c-d7e9-492e-b524-be0aeadbb403 61 fields · synced May 16, 2026
- EUDAMED fef234da-2e7b-4542-b736-97baae274bb2 61 fields · synced May 18, 2026
- EUDAMED 23138958-7ae5-4976-8d2a-ab8c0fe94e9b 61 fields · synced May 18, 2026