Identity
- Trade Name
- Metode Steril Sarkomp 10X10CM EUDAMED
- Device Name
- Wound Dressing EUDAMED
- Model / Reference
- 867099 EUDAMEDFW1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719884333291 EUDAMED
- Basic UDI-DI
- B-04719884333291 EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway 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
Metode Steril Sarkomp 10X10CM by Tronjen Medical Technology Inc. — 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-04719884333291 | Class I | Active |
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Manufacturer
- Manufacturer
- Tronjen Medical Technology Inc.
- EUDAMED SRN
- TW-MF-000035692
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 36768a40-d6ed-4831-8a30-f90f222363a0 61 fields · synced Jun 20, 2026
- EUDAMED 97db51d7-4984-4ae8-9cbc-09580bd91ad2 61 fields · synced Jun 20, 2026