Identity
- Trade Name
- Silver Spiro Foam Dressing EUDAMED
- Device Name
- Silver Spiro Foam Medium EUDAMED
- Model / Reference
- XF-SPMF1-AG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405000556 EUDAMED
- Basic UDI-DI
- B-00849405000556 EUDAMED
- EMDN Code
- M04040801 SILVER DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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
Silver Spiro Foam Dressing by Genadyne Biotechnologies Inc. — Class III — 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-00849405000556 | Class III | Active |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
- EUDAMED SRN
- US-MF-000017992
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 4585ade7-a5b9-42e2-939b-bc95994ee57c 61 fields · synced Jul 20, 2026