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Epimed International, Inc.
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 164-2014Model Spring Guide Epidural Catheter
Identity
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed FDA UDI
- Generic Name
- Epidural anaesthesia set, non-medicated FDA UDI
- Device Name
- Spirol® Open End 20g x 14" Styletted FDA UDI
- Model / Reference
- Spring Guide Epidural Catheter EUDAMED164-2014 EUDAMEDFDA UDI
- Description
- Spirol® Open End 20g x 14" Styletted FDA UDI
Identifiers
- Catalog Number
- 164-2014 FDA UDI
- Primary DI / UDI-DI
- 00818788022868 EUDAMEDFDA UDI
- Basic UDI-DI
- 081878802SGECH6 EUDAMED
- 510(k) Number
- K981329 FDA UDI
- FDA Product Code
- BSO FDA UDI
- EMDN Code
- N010401 PERIPHERAL NERVOUS SYSTEM CATHETERS AND KITS EUDAMED
- GMDN Term
- Epidural anaesthesia set, non-medicated FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5120 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
- Catheter Length — 14 Inch FDA UDICatheter Gauge — 2.7 French FDA UDI
Epimed International, Inc. by Epimed International, Inc — Class IIb — 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 | 081878802SGECH6 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 51347a5b-48d8-4337-80fd-2b8fe5f57cc2 61 fields · synced Jul 23, 2026
- FDA UDI 649f58bc-95bb-48a7-9e3e-50b2f7da143a 37 fields · synced May 30, 2026