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OptiTherm Sztuczny lód
EUDAMEDClass IIa (EU MDR)
Ref 5903686618338Model OptiTherm Sztuczny lód 200ml
Identity
- Trade Name
- OptiTherm Sztuczny lód EUDAMED
- Device Name
- OptiTherm Sztuczny lód EUDAMED
- Model / Reference
- OptiTherm Sztuczny lód 200ml EUDAMED5903686618338 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903686618338 EUDAMED
- Basic UDI-DI
- B-05903686618338 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
OptiTherm Sztuczny lód by Tecweld Piotr Polak — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Manufacturer's product page: Sztuczny lód ICEMIX
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05903686618338 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tecweld Piotr Polak
- EUDAMED SRN
- PL-MF-000050903
Sources (1)
- EUDAMED 25534d7d-3ece-4d4b-9131-a481bf1d0c5a 61 fields · synced Jul 21, 2026