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Physiolab S1 Unit
EUDAMEDClass IIa (EU MDR)
Ref S1 Control Unit - UK regionRef S1 Control Unit - Portuguese regionRef S1 Control Unit [E] French regionRef S1 Control Unit [E] Swedish regionRef S1 Control Unit [E] Spanish regionRef S1 Control Unit [E] Italian regionRef S1 Control Unit - Italian regionRef S1 Control Unit - French regionRef S1 Control Unit - Spanish regionRef S1 Control Unit - German regionRef S1 BATCH FRef S1 Control Unit - Swedish region Ref S1 BATCH ARef S1 Control Unit [E] BelgiumRef S1 Control Unit [E] Portuguese region
Identity
- Device Name
- Physiolab S1 Unit EUDAMED
- Model / Reference
- S1 Control Unit - UK region EUDAMEDS1 Control Unit - Portuguese region EUDAMEDS1 Control Unit [E] French region EUDAMEDS1 Control Unit [E] Swedish region EUDAMEDS1 Control Unit [E] Spanish region EUDAMEDS1 Control Unit [E] Italian region EUDAMEDS1 Control Unit - Italian region EUDAMEDS1 Control Unit - French region EUDAMEDS1 Control Unit - Spanish region EUDAMEDS1 Control Unit - German region EUDAMEDS1 BATCH F EUDAMEDS1 Control Unit - Swedish region EUDAMEDS1 BATCH A EUDAMEDS1 Control Unit [E] Belgium EUDAMEDS1 Control Unit [E] Portuguese region EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060538870020 EUDAMED05060538870075 EUDAMED05060538870556 EUDAMED05060538870600 EUDAMED05060538870587 EUDAMED05060538870570 EUDAMED05060538870051 EUDAMED05060538870037 EUDAMED05060538870068 EUDAMED05060538870044 EUDAMED05060538870532 EUDAMED05060538870082 EUDAMED05060538870112 EUDAMED05060538870624 EUDAMED05060538870594 EUDAMED
- Basic UDI-DI
- 506053887S1R4 EUDAMED
- Direct Marketing DI
- 05060538870020 EUDAMED05060538870075 EUDAMED05060538870556 EUDAMED05060538870600 EUDAMED05060538870587 EUDAMED05060538870570 EUDAMED05060538870051 EUDAMED05060538870037 EUDAMED05060538870068 EUDAMED05060538870044 EUDAMED05060538870532 EUDAMED05060538870082 EUDAMED05060538870112 EUDAMED05060538870624 EUDAMED05060538870594 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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Also classified as Hot/cold therapy pack, reusable.
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- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 (15)
- EUDAMED 722a8cc7-0643-4a8e-9983-c5058c4f0de3 61 fields · synced Sep 17, 2026
- EUDAMED cb156d8b-8533-4436-8419-114168bb22a3 61 fields · synced May 17, 2026
- EUDAMED 4e101794-e7ed-4e65-ab99-0b11a5823247 61 fields · synced May 17, 2026
- EUDAMED d8f7b3b2-8749-4873-b644-18fca4a1836e 61 fields · synced May 17, 2026
- EUDAMED a080b73f-5f53-4d77-950c-0627c0df6695 61 fields · synced May 17, 2026
- EUDAMED 512f57b2-8ffa-448d-b446-c3053c1454d3 61 fields · synced May 17, 2026
- EUDAMED 2f95f64e-61fc-4dc8-a2ac-244451339941 61 fields · synced May 18, 2026
- EUDAMED 2a8b8455-10a1-4c1b-97d4-e73f099645d7 61 fields · synced May 18, 2026
- EUDAMED 7577ee2d-37af-4006-a964-d8f8147dca00 61 fields · synced May 18, 2026
- EUDAMED 768894c2-d784-4350-a9b9-24ff7c19bd3b 61 fields · synced May 18, 2026
- EUDAMED c928de2d-9404-4f9a-afa4-bacfa825dec0 61 fields · synced May 18, 2026
- EUDAMED 1ae8e49e-4ad0-42b6-8cfb-5f779422e368 61 fields · synced May 18, 2026
- EUDAMED 80d92e03-c344-4763-b8f4-2e8ea002a90a 61 fields · synced May 18, 2026
- EUDAMED 4975a502-0c96-4640-9dcc-5f442f81f75f 61 fields · synced May 18, 2026
- EUDAMED bee39c59-581e-4135-955a-705bc545e42d 61 fields · synced May 19, 2026