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Epimed International, Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1911-319Model Nearaxial Catheter Connector
Identity
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed FDA UDI
- Generic Name
- Luer/Luer linear connector, single-use FDA UDI
- Device Name
- Stingray® Epidural Catheter Connector 19g FDA UDI
- Model / Reference
- Nearaxial Catheter Connector EUDAMED1911-319 EUDAMEDFDA UDI
- Description
- Stingray® Epidural Catheter Connector 19g FDA UDI
Identifiers
- Catalog Number
- 1911-319 FDA UDI
- Primary DI / UDI-DI
- 00818788021557 EUDAMEDFDA UDI
- Basic UDI-DI
- 081878802CathConnectorQW EUDAMED
- 510(k) Number
- K051171 FDA UDI
- FDA Product Code
- CAZ FDA UDI
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
- GMDN Term
- Luer/Luer linear connector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5140 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
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 | 081878802CathConnectorQW | 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 c485113b-818e-40c0-a0e7-19e7b9a14c6c 61 fields · synced Jun 20, 2026
- FDA UDI f9c94d0a-acf1-4e73-8d99-7a3ab74d23af 37 fields · synced May 30, 2026