Identity
- Trade Name
- SeeStar 14G EUDAMEDSeeStar FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- SeeStar EUDAMEDA passive guide for guided invasive access. FDA UDI
- Model / Reference
- 13314 EUDAMEDG050 FDA UDI
- Description
- A passive guide for guided invasive access. FDA UDI
Identifiers
- Catalog Number
- 13314 FDA UDI
- Primary DI / UDI-DI
- 07350031350500 EUDAMEDFDA UDI
- Basic UDI-DI
- 73500313514KN EUDAMED
- FDA Product Code
- GDF FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Sweden 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
No
EUDAMED
Measuring Function
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDI
SeeStar 14G by Apriomed AB — Class I — 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 | 73500313514KN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AprioMed AB
- EUDAMED SRN
- SE-MF-000001013
Sources (2)
- EUDAMED 2a7a7ee4-88e3-42ae-96ec-3ed4c2dab85f 61 fields · synced Jul 18, 2026
- FDA UDI 5e914776-df59-464d-8875-92dc7707ea16 36 fields · synced May 30, 2026