Identity
- Trade Name
- HemoWeld-T EUDAMEDFDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- Sealer EUDAMEDBench tube sealer for medical PVC tubes FDA UDI
- Model / Reference
- HWELD-T.DB.00 EUDAMEDFDA UDI
- Description
- Bench tube sealer for medical PVC tubes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928530115 EUDAMEDFDA UDI
- Basic UDI-DI
- 803392853SEALFP EUDAMED
- Direct Marketing DI
- 08033928530115 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-T 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 |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (2)
- EUDAMED 45e9ac65-6b2c-4757-8d83-839c814af1b3 61 fields · synced Jul 23, 2026
- FDA UDI 40f4c23c-b25d-455c-9170-9b31e8271a3f 33 fields · synced May 30, 2026