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Disposable Double Hook Nerve Stimulator Probes
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1357Model PNHModel 017512
Identity
- Trade Name
- Natus EUDAMEDFDA UDI
- Generic Name
- Nerve-locating system probe, single-use FDA UDI
- Device Name
- Disposable Double Hook Nerve Stimulator Probes EUDAMED
- Model / Reference
- PNH EUDAMED1357 EUDAMED017512 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 16955739013573 EUDAMEDFDA UDI
- Basic UDI-DI
- 695573903011LC EUDAMEDB-16955739013573 EUDAMED
- 510(k) Number
- K112426 FDA UDI
- FDA Product Code
- ETN FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Nerve-locating system probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Market of Registration
- Italy 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
Ethylene Oxide FDA UDI
Disposable Double Hook Nerve Stimulator Probes by Xi'an Friendship Medical Electronics Co., Ltd. — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112426 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 695573903011LC | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 695573903011LC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xi'an Friendship Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004202
- Authorised Representative
- Friendship Europe ApS DK-AR-000001593
Sources (4)
- EUDAMED 2ae56b26-a9a7-432e-b843-a0d75ac417c6 61 fields · synced Oct 6, 2026
- EUDAMED 6bdc0516-8175-4dac-a483-2f8d951abb0b 61 fields · synced May 17, 2026
- FDA UDI add536a5-0b5e-40b9-a42d-cf39c79e8cb3 33 fields · synced May 30, 2026
- FDA 510(k) K112426 1 fields · synced May 18, 2026