Epimed International, Inc.
by Epimed International, Inc. United States EUDAMEDGUDID
Ref 131-2245Model Nerve Block Needle Product code BSPEMDN A0199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | Number081878802NBNLS | Date29 Jul 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number081878802NBNLS | Date29 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00818788023438 | Date23 Jul 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed GUDID
- Generic Name
- Peripheral nerve-block sharp needle
- Model / Ref / Catalog
- Nerve Block Needle, 131-2245
- Primary DI / UDI-DI
- 00818788023438
- Basic UDI-DI
- 081878802NBNLS, B-00818788023438
- 510(k) Number
- FDA Product Code
- BSP
- EMDN Code
- A0199 Needles - other
- GMDN Term
- Peripheral nerve-block sharp needle
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 868.5150
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
- MRI Safety
- MR Unsafe
- Size
- Needle Gauge — 22 GaugeLength — 4.5 Inch
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000010774
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Epimed International, Inc
Properties & raw data
Show properties, registry sources and raw records
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: 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 43d4cecc-88a0-408a-a4b4-ce3e21957995
- FDA UDI 8ef267e4-9a04-4846-b3c5-c56cbaca3558
- EUDAMED 00818788023438|B-00818788023438