Identity
- Trade Name
- PAMSys EUDAMED
- Device Name
- PAMSys EUDAMED
- Model / Reference
- +B654PM0S EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B654PM0S EUDAMED
- Basic UDI-DI
- ++B654PMB5 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
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
Category: Device sterilization/disinfection container, reusable
PAMSys by BioSensics, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++B654PMB5 | Class I | Active |
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Manufacturer
- Manufacturer
- BioSensics, LLC
- EUDAMED SRN
- US-MF-000040296
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 76ead197-81ac-49a8-9698-e2d4661a66bb 61 fields · synced Jun 18, 2026