Identity
- Trade Name
- Sterile electrode's cable EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Cables EUDAMED
- Model / Reference
- STR-000526-11 EUDAMEDSterile electrode's cable FDA UDI
Identifiers
- Catalog Number
- STR-000526-11 FDA UDI
- Primary DI / UDI-DI
- 07290114061575 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011406123CABFB EUDAMED
- 510(k) Number
- K120098 FDA UDI
- FDA Product Code
- GZL FDA UDI
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1330 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Sterile electrode's cable by Alpha Omega Engineering Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 729011406123CABFB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alpha Omega Engineering Ltd
- EUDAMED SRN
- IL-MF-000025214
- Authorised Representative
- Alpha Omega GmbH DE-AR-000022420
Sources (2)
- EUDAMED 7e5a6e8b-9982-4065-987b-5ab226ce990e 61 fields · synced May 30, 2026
- FDA UDI 22ec3218-8e98-410f-838e-52c78c9ba5bf 34 fields · synced May 30, 2026