Identity
- Trade Name
- PLS Harness Set EUDAMED
- Device Name
- PLS Harness Set EUDAMED
- Model / Reference
- 00620-NX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10812747019859 EUDAMED
- Basic UDI-DI
- 081274701PLS0053S EUDAMED
- EMDN Code
- B030101 APHERESIS PLASMA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class IIa 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 Harness Set by Haemonetics Corporation — Class IIa — 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 | 081274701PLS0053S | Class IIa | Active |
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Manufacturer
- Manufacturer
- Haemonetics Corporation
- EUDAMED SRN
- US-MF-000034539
- Authorised Representative
- Haemonetics Italia s.r.l IT-AR-000021067
Sources (1)
- EUDAMED 45027395-e0e0-4e42-bf12-26c56d0cf6fa 61 fields · synced Jun 18, 2026