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Epimed International, Inc.
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 159-2112Model Spring Guide Epidural Catheter
Identity
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed FDA UDI
- Generic Name
- Epidural anaesthesia set, non-medicated FDA UDI
- Device Name
- Versa-Kath® with Small Bore Connector 21g x 12" FDA UDI
- Model / Reference
- Spring Guide Epidural Catheter EUDAMED159-2112 EUDAMEDFDA UDI
- Description
- Versa-Kath® with Small Bore Connector 21g x 12" FDA UDI
Identifiers
- Catalog Number
- 159-2112 FDA UDI
- Primary DI / UDI-DI
- 00818788023551 EUDAMEDFDA UDI
- Basic UDI-DI
- 081878802SGECH6 EUDAMED
- 510(k) Number
- K023140 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
Yes
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 Gauge — 2.4 French FDA UDILength — 12 Inch 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 1fed0ba7-9aa4-4f53-86d8-37fefd087602 61 fields · synced Jun 4, 2026
- FDA UDI 0722c5b5-15fd-47f3-a1ff-eefeb12baf6b 38 fields · synced May 30, 2026