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Epimed International, Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 130-2545Model Nerve Block Needle
Identity
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed FDA UDI
- Generic Name
- Peripheral nerve-block sharp needle FDA UDI
- Device Name
- 25g TW x 4.5" Quincke Spinal Needle w/ Introducer FDA UDI
- Model / Reference
- Nerve Block Needle EUDAMED130-2545 EUDAMEDFDA UDI
- Description
- 25g TW x 4.5" Quincke Spinal Needle w/ Introducer FDA UDI
Identifiers
- Catalog Number
- 130-2545 FDA UDI
- Primary DI / UDI-DI
- 00818788020888 EUDAMEDFDA UDI
- Basic UDI-DI
- 081878802NBNLS EUDAMED
- 510(k) Number
- K022029 FDA UDI
- FDA Product Code
- BSP FDA UDI
- EMDN Code
- A0199 NEEDLES - OTHER EUDAMED
- GMDN Term
- Peripheral nerve-block sharp needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5150 FDA UDI
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Measuring Function
Yes
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDILength — 4.5 Inch FDA UDI
Category: Hypodermic needle, single-use
Epimed International, Inc. by Epimed International, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081878802NBNLS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Epimed International, Inc.
- EUDAMED SRN
- US-MF-000010774
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 967add86-299a-4aac-b3ad-89fef371f449 61 fields · synced Jul 16, 2026
- FDA UDI 8fe0d8c2-1e80-4794-a725-a6efaaea4441 38 fields · synced May 30, 2026