← Back to catalogue
Disposable Corkscrew Needle Electrodes(Twisted)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1351Model NES-D2Model 017506
Identity
- Trade Name
- Natus EUDAMEDFDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Disposable Corkscrew Needle Electrodes(Twisted) EUDAMED
- Model / Reference
- NES-D2 EUDAMED1351 EUDAMED017506 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 16955739013511 EUDAMEDFDA UDI
- Basic UDI-DI
- 695573901007L7 EUDAMEDB-16955739013511 EUDAMED
- 510(k) Number
- K072276 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 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 Corkscrew Needle Electrodes(Twisted) by Xi'an Friendship Medical Electronics Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 695573901007L7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 695573901007L7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xi'an Friendship Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004202
- Authorised Representative
- Friendship Europe ApS DK-AR-000001593
Sources (3)
- EUDAMED bd01d932-f1fe-44b6-983b-6c496f41a1b2 61 fields · synced Oct 6, 2026
- EUDAMED ff192bf6-adf7-4a5c-aa49-a79277f6b10e 61 fields · synced May 17, 2026
- FDA UDI 2602fe52-8677-4f13-b9e2-0ad4e86a7e53 33 fields · synced May 30, 2026