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Plasma Set, HS Bowl
EUDAMEDClass IIb (EU MDR)
Ref 782HS-P-SLModel Plasma Collection Sets with HS bowl
Identity
- Trade Name
- Plasma Set, HS Bowl EUDAMED
- Model / Reference
- Plasma Collection Sets with HS bowl EUDAMED782HS-P-SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10812747019125 EUDAMED
- Basic UDI-DI
- 081274701PLS0123P EUDAMED
- EMDN Code
- B030101 APHERESIS PLASMA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Plasma Set, HS Bowl by Haemonetics S.A. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081274701PLS0123P | Class IIb | Active |
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Manufacturer
- Manufacturer
- Haemonetics S.A.
- EUDAMED SRN
- CH-MF-000034549
- Authorised Representative
- Haemonetics Italia s.r.l IT-AR-000021067
Sources (1)
- EUDAMED 5ea4a379-e38c-4ed8-b23e-80628dce5d9b 61 fields · synced Jul 24, 2026