Friendship Medical
by Xi'an Friendship Medical Electronics Co., Ltd. China EUDAMEDGUDID
Ref 3023Model PNM, PNM0.8/200
Product code ETNEMDN Z121002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number695573903000L7 | Date12 Jun 2024 | StatusActive |
| United States | GUDID listing GUDID | Number16955739030235 | Date14 Apr 2017 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Nerve-locating system probe, single-use
- Device Name
- Disposable Monopolar Nerve Stimulator Probe
- Model / Reference
- PNM, 3023, PNM0.8/200
- Primary DI / UDI-DI
- 16955739030235
- Basic UDI-DI
- 695573903000L7, B-16955739030235
- 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 |
|---|---|---|
| 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 (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: 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 (3)
- EUDAMED 333f00b6-f8ad-430e-b85e-96fc3d04888b
- FDA UDI 4c87403e-c8e6-46ca-8fd6-86a18f02c08b
- EUDAMED 16955739030235|B-16955739030235