Identity
- Trade Name
- Foam Dressing Medium Instill EUDAMED
- Device Name
- Foam Dressing Medium Spiro Instill EUDAMED
- Model / Reference
- XF-SPMF1i EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405002260 EUDAMED
- Basic UDI-DI
- B-00849405002260 EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb 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
Foam Dressing Medium Instill by Genadyne Biotechnologies Inc. — Class IIb — 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-00849405002260 | Class IIb | 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 c51feaaf-6fd8-4a7d-86df-74aa9348bbba 61 fields · synced Jul 24, 2026