Identity
- Trade Name
- Cold Therapy Bags EUDAMED
- Device Name
- Direct Stick FirstIce Cryotherapy Bag EUDAMED
- Model / Reference
- 13422-00-90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08836913456014 EUDAMED
- Basic UDI-DI
- 088369113422E7 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Cold Therapy Bags by Professional Products, Inc. — Class I — 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 | 088369113422E7 | Class I | Active |
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Manufacturer
- Manufacturer
- Professional Products, Inc.
- EUDAMED SRN
- US-MF-000019828
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d43721b0-2bd7-4caf-b04c-6201939a6962 61 fields · synced Jun 18, 2026