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Epimed International, Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 122-2080Model Nerve Block Needle
Identity
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed FDA UDI
- Generic Name
- Peripheral nerve-block blunt needle FDA UDI
- Device Name
- 20g RW x 8.0" Day Needle Bullet Tip Coudé® FDA UDI
- Model / Reference
- Nerve Block Needle EUDAMED122-2080 EUDAMEDFDA UDI
- Description
- 20g RW x 8.0" Day Needle Bullet Tip Coudé® FDA UDI
Identifiers
- Catalog Number
- 122-2080 FDA UDI
- Primary DI / UDI-DI
- 00818788020741 EUDAMEDFDA UDI
- Basic UDI-DI
- 081878802NBNLS EUDAMED
- 510(k) Number
- K041843 FDA UDI
- FDA Product Code
- BSP FDA UDI
- EMDN Code
- A019001 BLUNT NEEDLES EUDAMED
- GMDN Term
- Peripheral nerve-block blunt 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 — 20 Gauge FDA UDILength — 8 Inch FDA UDI
Epimed International, Inc. by Epimed International, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 3252d06b-fefe-498e-926c-41c8851d6c95 61 fields · synced Jun 4, 2026
- FDA UDI 87dc7e4c-ea30-4aca-a6f3-646dcef8059c 38 fields · synced May 30, 2026