← Back to catalogue
HemoWeld Gun - Suitcase
EUDAMEDFDA UDIClass I (EU MDR)
Ref HWG2.00V
by Delcon Srl
Identity
- Trade Name
- HemoWeld Gun - Suitcase EUDAMEDHemoWeld-Gun FDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- Sealer EUDAMEDPortable sealer for blood bag tubes - Case Kit FDA UDI
- Model / Reference
- HWG2.00V EUDAMEDFDA UDI
- Description
- Portable sealer for blood bag tubes - Case Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928530139 EUDAMEDFDA UDI
- Basic UDI-DI
- 803392853SEALFP EUDAMED
- Direct Marketing DI
- 08033928530139 EUDAMED
- FDA Product Code
- KSD FDA UDI
- EMDN Code
- B0180 BLOOD BAGS AND KITS - ACCESSORIES EUDAMED
- GMDN Term
- Blood donor bag tube divider/sealer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.9750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HemoWeld Gun - Suitcase by Delcon Srl — 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 | 803392853SEALFP | 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
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (2)
- EUDAMED 3e23a8b5-6267-4076-b3d7-85d90a0a25d2 61 fields · synced Aug 4, 2026
- FDA UDI 5c9832f0-1017-4b98-9678-cfa17133d86f 33 fields · synced May 30, 2026