Identity
- Device Name
- Vented Instrument Guards EUDAMED
- Model / Reference
- GH-09-2-018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848956011691 EUDAMED
- Basic UDI-DI
- 08489560OthersPW EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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: Device sterilization/disinfection container, reusable
Vented Instrument Guards by Healthmark Industries Co., Inc. — 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 | 08489560OthersPW | Class I | Active |
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Manufacturer
- Manufacturer
- Healthmark Industries CO INC
- EUDAMED SRN
- US-MF-000047536
- Authorised Representative
- LTA MEDICAL FR-AR-000040145
Sources (1)
- EUDAMED 8454619b-ae0a-47d9-aa84-930f65ba3941 61 fields · synced Jun 17, 2026