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Epimed International, Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 106-1618Model Epidural Introducer Needle
Identity
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed FDA UDI
- Generic Name
- Epidural needle, non-threaded FDA UDI
- Device Name
- RX Epidural Needle 18g TW x 6.0" FDA UDI
- Model / Reference
- Epidural Introducer Needle EUDAMED106-1618 EUDAMEDFDA UDI
- Description
- RX Epidural Needle 18g TW x 6.0" FDA UDI
Identifiers
- Catalog Number
- 106-1618 FDA UDI
- Primary DI / UDI-DI
- 00818788020536 EUDAMEDFDA UDI
- Basic UDI-DI
- 081878802EINL2 EUDAMED
- 510(k) Number
- K053318 FDA UDI
- FDA Product Code
- BSP FDA UDI
- EMDN Code
- A01030102 EPIDURAL ANAESTHESIA NEEDLES AND KITS EUDAMED
- GMDN Term
- Epidural needle, non-threaded 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 — 18 Gauge FDA UDILength — 6 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 | 081878802EINL2 | 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 ff5a8126-d85b-4a40-9439-94f8829db846 61 fields · synced Jul 31, 2026
- FDA UDI 33d74590-dc29-4fc5-a4e6-69a8470a9839 38 fields · synced May 29, 2026