Identity
- Trade Name
- Metode Steril Sarkomp 5X7,5CM EUDAMED
- Device Name
- Wound Dressing EUDAMED
- Model / Reference
- 961320 EUDAMEDFW7550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719884333321 EUDAMED
- Basic UDI-DI
- B-04719884333321 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 5X7, 5CM 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-04719884333321 | 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 d8ccb985-b4da-48c8-a44a-0c3a49ebcdb3 61 fields · synced Jul 23, 2026
- EUDAMED e2ffce88-7317-4315-8956-a0c5e31df63c 61 fields · synced Jul 23, 2026