Identity
- Trade Name
- Guanti cotone 100% elast. verde 10 EUDAMED
- Device Name
- Guanti in filato EUDAMED
- Model / Reference
- 01GCEV010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056977983336 EUDAMED
- Basic UDI-DI
- 80569779801GC09Q EUDAMED
- EMDN Code
- T0199 GLOVES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Category: Radiation shielding apron
Guanti cotone 100% elast. verde 10 by Megapharma Ospedaliera s.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiation shielding apron.
- K303 — BURLINGTON MEDICAL, LLC · Class I
- Palmero Healthcare, LLC — PALMERO HEALTHCARE LLC · Class I
- FVEST — BURLINGTON MEDICAL, LLC · Class I
- THYROID SHIELD — BURLINGTON MEDICAL, LLC · Class I
- BLOCKER — BURLINGTON MEDICAL, LLC · Class I
- THYROID SHIELD — BURLINGTON MEDICAL, LLC · Class I
- Euro — BURLINGTON MEDICAL, LLC · Class I
- Fast Wrap Apron — Shielding International Inc. · Class I
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 | 80569779801GC09Q | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Megapharma Ospedaliera s.r.l.
- EUDAMED SRN
- IT-MF-000010739
Sources (1)
- EUDAMED 2a296f41-64bc-4646-b5d7-4a8eb69d2053 61 fields · synced Jul 9, 2026