Identity
- Trade Name
- HS PLS Bowl EUDAMED
- Device Name
- HS PLS Bowl EUDAMED
- Model / Reference
- 625HS-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10812747011792 EUDAMED
- Basic UDI-DI
- 081274701PLS0113M EUDAMED
- EMDN Code
- B030101 APHERESIS PLASMA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
HS PLS Bowl 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 | 081274701PLS0113M | 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 f0b7a55d-acd5-4d60-a9fd-96b9030a75d1 61 fields · synced Jul 10, 2026