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HeltiQ plaster
EUDAMEDClass I (EU MDR)
Ref 1200241Model 72x19mm, 56x19mm, 45x19mm, 40x10mm, 72x25mm, 76x38mm, 60x60mm, 63x25mm, 57x16mm, 76x19mm, 76x25mm, 38x32mm, 38x38mm, 120x20mm, 6cmx1m, 6x10cm, 6cmx5m, φ35,45mm, etc.
Identity
- Trade Name
- HeltiQ plaster EUDAMED
- Device Name
- Adhesive Plaster EUDAMED
- Model / Reference
- 72x19mm, 56x19mm, 45x19mm, 40x10mm, 72x25mm, 76x38mm, 60x60mm, 63x25mm, 57x16mm, 76x19mm, 76x25mm, 38x32mm, 38x38mm, 120x20mm, 6cmx1m, 6x10cm, 6cmx5m, φ35,45mm, etc. EUDAMED1200241 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717484793138 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IN0000024L EUDAMED
- Unit of Use DI
- 08717484794012 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
HeltiQ plaster by RFX+CARE Manufacturing Co., Ltd. — 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 | 69228209MDN1204IN0000024L | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED 9f93d0ba-0860-4120-aafe-9382fef5e8ce 61 fields · synced Jun 18, 2026