Identity
- Device Name
- Physiolab S1 Unit EUDAMED
- Model / Reference
- S1 BATCH D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060538870129 EUDAMED
- Basic UDI-DI
- 506053887S1R4 EUDAMED
- Direct Marketing DI
- 05060538870129 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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: Hot/cold therapy pack, reusable
Physiolab S1 Unit by Physiolab Technologies Ltd — Class IIa — 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 | 506053887S1R4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Physiolab Technologies Ltd
- EUDAMED SRN
- GB-MF-000010454
- Authorised Representative
- Medical Device Management Ltd IE-AR-000002496
Sources (1)
- EUDAMED 22a8c4d2-0b81-4d1a-8c22-155d040c744f 61 fields · synced Jul 10, 2026