Identity
- Trade Name
- MacoSeal PS2-AS EUDAMEDFDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- MacoSeal PS2-AS EUDAMEDThe MacoSeal PS2-AS is a portable and fully automatic system for sealing PVC tubes, especially tubes in blood pack systems. It performs pre-cut welding on wet or dry tube using high frequency. The MacoSeal PS2-AS can be used either in fixed collection or in mobile collection or preparation site. FDA UDI
- Model / Reference
- 9HPS2-AS EUDAMEDPS2-AS FDA UDI
- Description
- The MacoSeal PS2-AS is a portable and fully automatic system for sealing PVC tubes, especially tubes in blood pack systems. It performs pre-cut welding on wet or dry tube using high frequency. The MacoSeal PS2-AS can be used either in fixed collection or in mobile collection or preparation site. FDA UDI
Identifiers
- Catalog Number
- PS2-AS FDA UDI
- Primary DI / UDI-DI
- 03567050071970 EUDAMEDFDA UDI
- Basic UDI-DI
- 356705TPS2AS0CX EUDAMED
- FDA Product Code
- KSD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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
- Greece 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
Category: Device sterilization/disinfection container, reusable
MacoSeal PS2-AS by Maco Pharma — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- APTUS — Medartis Inc. · Class I
- APTUS — Medartis Inc. · Class II
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
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 | 356705TPS2AS0CX | 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
- Maco Pharma
- EUDAMED SRN
- FR-MF-000001657
Sources (2)
- EUDAMED 6cca5826-c1a6-480b-a6f1-8062f4246b7d 61 fields · synced Jul 29, 2026
- FDA UDI 53659b5a-7a2d-4d00-8f26-cd513ad0a45b 35 fields · synced May 30, 2026