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Reusable Unshielded Cable for detachable monopolar EMG needle electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref TE/D34-231
Identity
- Trade Name
- Reusable Unshielded Cable for detachable monopolar EMG needle electrode EUDAMEDTechnomed Europe FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- Reusable EMG cables EUDAMEDReusable Unshielded Cable, for detachable monopolar EMG needle electrode, DIN 42802 connector FDA UDI
- Model / Reference
- TE/D34-231 EUDAMEDFDA UDI
- Description
- Reusable Unshielded Cable, for detachable monopolar EMG needle electrode, DIN 42802 connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375860953 EUDAMEDFDA UDI
- Basic UDI-DI
- 8718375860001BZ EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 600 Millimeter FDA UDI
Reusable Unshielded Cable for detachable monopolar EMG needle electrode by Technomed Europe — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8718375860001BZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED 40080d41-3b03-4ec8-ae6f-5cd1f3cd0271 61 fields · synced Jul 10, 2026
- FDA UDI 06e344a1-b014-42c0-8b04-3f0fcf72ec63 35 fields · synced May 30, 2026