Friendship Medical
by Xi'an Friendship Medical Electronics Co., Ltd. China EUDAMEDGUDID
Ref 3020Model PNN0.3/13
Product code ETNEMDN Z121002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-16955739030204 | Date22 Feb 2022 | StatusActive |
| United States | GUDID listing GUDID | Number16955739030204 | Date17 Aug 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Nerve-locating system probe, single-use
- Device Name
- Disposable Needle Stimulator Probe
- Model / Reference
- PNN0.3/13 EUDAMED3020 EUDAMEDPNN 0.3/13 GUDID
- Primary DI / UDI-DI
- 16955739030204
- Basic UDI-DI
- B-16955739030204
- 510(k) Number
- FDA Product Code
- ETN
- EMDN Code
- Z121002 Nervous system monitoring systems
- GMDN Term
- Nerve-locating system probe, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 874.1820
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | PNN0.3/13 3020 | PNN 0.3/13 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000004202
- Authorised representative
- Friendship Europe ApS DK-AR-000001593
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Properties & raw data
Show properties, registry sources and raw records
Other properties (16)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (2)
- EUDAMED 72314ef5-3ae9-4fa9-a2d4-a3021aed1cc2
- FDA UDI 653c21ee-166d-43a8-b1c6-4de4a33775fa