← Back to catalogue
Sterile Sclerotherapy & Endoscopic Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GF252203
Identity
- Trade Name
- Sterile Sclerotherapy & Endoscopic Needles EUDAMEDG-Flex FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Sterile Sclerotherapy & Endoscopic Needles EUDAMEDSclerotherapy Needle - Calibra FDA UDI
- Model / Reference
- GF252203 EUDAMEDFDA UDI
- Description
- Sclerotherapy Needle - Calibra FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05420051301041 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200513-TF10-SCL-SU-DC EUDAMED
- FDA Product Code
- FBK FDA UDI
- EMDN Code
- G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile Sclerotherapy & Endoscopic Needles by G-Flex Flexible Instruments Europe — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 54200513-TF10-SCL-SU-DC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (2)
- EUDAMED e58e28c3-a635-41c4-9ed6-2b12c125766e 61 fields · synced Jun 18, 2026
- FDA UDI 1a0df1a5-c0d8-4681-946e-b112a8596946 33 fields · synced May 30, 2026