Identity
- Trade Name
- MacoSeal LIGHT EUDAMEDFDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- MacoSeal LIGHT EUDAMEDMacoSeal LIGHT is a cordless, automatic, and portable tube sealer, designed for sealing tubing of blood bags systems. This sealer can be used in both fixed and mobile collection sites, as well as in preparation sites, to hermetically seal PVC tubing in an automatic operation that ensures the reproducible quality, width and separation of sealings. It is composed of three (3) mobile parts sold together, not separately. FDA UDI
- Model / Reference
- 9MSLIGHT00 EUDAMEDFDA UDI
- Description
- MacoSeal LIGHT is a cordless, automatic, and portable tube sealer, designed for sealing tubing of blood bags systems. This sealer can be used in both fixed and mobile collection sites, as well as in preparation sites, to hermetically seal PVC tubing in an automatic operation that ensures the reproducible quality, width and separation of sealings. It is composed of three (3) mobile parts sold together, not separately. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03567050073097 EUDAMEDFDA UDI
- Basic UDI-DI
- 356705TMASL30BC EUDAMED
- Direct Marketing DI
- 03567050073097 EUDAMED
- FDA Product Code
- KSD FDA UDI
- EMDN Code
- Z121780 BLOOD TRANSFUSION INSTRUMENTS - HARDWARE 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
MacoSeal LIGHT by Maco Pharma — 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 | 356705TMASL30BC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maco Pharma
- EUDAMED SRN
- FR-MF-000001657
Sources (2)
- EUDAMED 796a6a60-49a3-40b0-b72e-e6d8a0845ef6 61 fields · synced Jul 24, 2026
- FDA UDI d1323242-8823-4737-8e69-3c2acdcabef5 33 fields · synced May 30, 2026