Identity
- Trade Name
- Topifoam EUDAMED
- Device Name
- Compression Foam EUDAMED
- Model / Reference
- 5710-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850014883164 EUDAMED
- Basic UDI-DI
- 0850014883BTD003PT EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD 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
Topifoam by Biodermis Llc — 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 | 0850014883BTD003PT | Class I | Active |
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Manufacturer
- Manufacturer
- Biodermis Llc
- EUDAMED SRN
- US-MF-000010640
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED f0c467ec-6012-43ab-805c-8a26714b937f 61 fields · synced Jul 23, 2026