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Acureal Liquid Wound Dressing
EUDAMEDClass I (EU MDR)
Ref LWD10Ref LWD15Model Silicone Dressings, Non-Combined
Identity
- Device Name
- Acureal Liquid Wound Dressing EUDAMED
- Model / Reference
- LWD10 EUDAMEDSilicone Dressings, Non-Combined EUDAMEDLWD15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710614725072 EUDAMED04710614721791 EUDAMED
- Basic UDI-DI
- 471061472507I4022006935PY EUDAMED471061472179I4025004354W8 EUDAMED
- Direct Marketing DI
- 04710614725072 EUDAMED04710614721791 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMEDM04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Acureal Liquid Wound Dressing by Bioptik Technology, Inc. Hsinchu Science Park Branch — 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 | 471061472507I4022006935PY | Class I | Active |
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Manufacturer
- Manufacturer
- Bioptik Technology, Inc. Hsinchu Science Park Branch
- EUDAMED SRN
- TW-MF-000047723
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (2)
- EUDAMED fd0d1014-cef0-42a2-8e0c-facd4b0c9d65 61 fields · synced Jul 28, 2026
- EUDAMED a02eebf2-4b95-48ee-bcbc-f2f5e127bb41 61 fields · synced Jul 14, 2026