Identity
- Trade Name
- GuardaCare PRO 2"x2", 8ply EUDAMED
- Device Name
- GuardaCare PRO 2"x2", 8ply EUDAMED
- Model / Reference
- 1012 (IT) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00870053000445 EUDAMED
- Basic UDI-DI
- B-00870053000445 EUDAMED
- EMDN Code
- M0202010101,M040501 EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
GuardaCare PRO 2"x2", 8ply by Tricol Biomedical, 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-00870053000445 | Class III | Active |
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Manufacturer
- Manufacturer
- Tricol Biomedical Inc
- EUDAMED SRN
- US-MF-000002003
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 1cc2e829-1bb4-4a6a-a78c-65cddbd99d57 61 fields · synced Sep 17, 2026