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Medical Scar Patch
EUDAMEDClass I (EU MDR)
Ref 8×3cm2Model (Unit: cm2): 8×3, 10×3, 12×3, 12×6, 12×8, 20×3, 20×12, 20×16.or customized
Identity
- Device Name
- Medical Scar Patch EUDAMED
- Model / Reference
- (Unit: cm2): 8×3, 10×3, 12×3, 12×6, 12×8, 20×3, 20×12, 20×16.or customized EUDAMED8×3cm2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921435100216 EUDAMED
- Basic UDI-DI
- 69214351MSP01MQ EUDAMED
- EMDN Code
- M04010203 FIXATION SILICONE DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Medical Scar Patch by Foshan Pingchuang Medical Technology 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 | 69214351MSP01MQ | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Pingchuang Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000039000
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7b9d39a0-9991-4712-850d-134502aefaea 61 fields · synced Jun 19, 2026