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Friendship Medical
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3013Model PNH1.2/80×3×100˚
Identity
- Trade Name
- Friendship Medical EUDAMEDFDA UDI
- Generic Name
- Nerve-locating system probe, single-use FDA UDI
- Device Name
- Disposable Triple Hook Nerve Stimulator Probes EUDAMED
- Model / Reference
- PNH1.2/80×3×100˚ EUDAMEDFDA UDI3013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955739030136 EUDAMEDFDA UDI
- Basic UDI-DI
- B-16955739030136 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Friendship Medical by Xi'an Friendship Medical Electronics Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16955739030136 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 2ac15239-5307-4274-bf5a-3997d8781404 61 fields · synced Oct 6, 2026
- FDA UDI 60a2d0cc-8ebb-488e-b2d3-a79e70d526d6 33 fields · synced May 30, 2026