Identity
- Trade Name
- PTFE Aragó EUDAMED
- Device Name
- Sutura PTFE EUDAMED
- Model / Reference
- 56019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427599028413 EUDAMED
- Basic UDI-DI
- 8427599DTTF02179 EUDAMED
- EMDN Code
- H010201010501 POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Category: Polyolefin/fluoropolymer suture, monofilament
PTFE Aragó by Laboratorio Aragó S.L. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8427599DTTF02179 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Laboratorio Aragó S.L.
- EUDAMED SRN
- ES-MF-000001958
Sources (1)
- EUDAMED 739b8cc2-2151-49a0-8c04-e75c8a970a20 61 fields · synced Oct 6, 2026