Identity
- Trade Name
- Pre-Op Glove EUDAMED
- Device Name
- Pre-Op Gloves EUDAMED
- Model / Reference
- Pre-Op Gloves EUDAMEDPOG-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00643293029176 EUDAMED
- Basic UDI-DI
- 00643293POGlove34 EUDAMED
- EMDN Code
- T0199 GLOVES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Pre-Op Glove by Trulife — Class I — 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 | 00643293POGlove34 | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (1)
- EUDAMED 707a76b6-6dad-4b37-94dd-599e57da3d20 61 fields · synced Jul 9, 2026