← Back to catalogue
PLS Bundled Sets w/Saline Line
EUDAMEDClass IIb (EU MDR)
Ref 00783-00Model Plasma Collection Sets with BMB bowl
Identity
- Trade Name
- PLS Bundled Sets w/Saline Line EUDAMED
- Model / Reference
- Plasma Collection Sets with BMB bowl EUDAMED00783-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10812747011785 EUDAMED
- Basic UDI-DI
- 081274701PLS0083Y EUDAMED
- EMDN Code
- B030101 APHERESIS PLASMA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
PLS Bundled Sets w/Saline Line 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 | 081274701PLS0083Y | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Haemonetics S.A.
- EUDAMED SRN
- CH-MF-000034549
- Authorised Representative
- Haemonetics Italia s.r.l IT-AR-000021067
Sources (1)
- EUDAMED b5b646d6-de7d-40e1-9c49-48b84a2d4482 61 fields · synced Jul 11, 2026