Identity
- Trade Name
- PROEMG FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- EMG Needle Electrode EUDAMEDMonopolar Needle, Non-Wired, 25mm(L)x0.45mm(D), Gray Hub FDA UDI
- Model / Reference
- BM2526 EUDAMEDFDA UDI
- Description
- Monopolar Needle, Non-Wired, 25mm(L)x0.45mm(D), Gray Hub FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809083944605 EUDAMEDFDA UDI
- Basic UDI-DI
- 880908394070KW EUDAMED
- 510(k) Number
- K152984 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
EMG Needle Electrode by Bio Protech Inc. — Class IIa — 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 | 880908394070KW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- EUDAMED SRN
- KR-MF-000012687
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED 82a6bbf3-9a23-433f-910e-cea7eb060a20 61 fields · synced Jul 19, 2026
- FDA UDI 37a659eb-e24c-44d0-a760-a5c3f61cfa85 35 fields · synced May 30, 2026