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Cutiderm Super Absorbent Wound Dressing 10x10cm - Pack of 10
EUDAMEDClass I (EU MDR)
Ref 409.008001
Identity
- Trade Name
- Cutiderm Super Absorbent Wound Dressing 10x10cm - Pack of 10 EUDAMED
- Device Name
- Absorbent Pads EUDAMED
- Model / Reference
- 409.008001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26958868784007 EUDAMED
- Basic UDI-DI
- B-26958868784007 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Cutiderm Super Absorbent Wound Dressing 10x10cm - Pack of 10 by Roosin Medical Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-26958868784007 | Class I | Active |
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Manufacturer
- Manufacturer
- Roosin Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021163
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED ac306d5e-f994-4082-980d-bd65c4311465 61 fields · synced Oct 6, 2026