Identity
- Device Name
- Equipment Instrument covers EUDAMED
- Model / Reference
- FLHC1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888277427495 EUDAMED
- Basic UDI-DI
- 0888277DC080CSTK7 EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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: Vascular booties
Equipment Instrument covers by Medline International France — 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 | 0888277DC080CSTK7 | Class I | Active |
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Manufacturer
- Manufacturer
- Medline International France SAS
- EUDAMED SRN
- FR-MF-000000676
Sources (1)
- EUDAMED cc5ee6cc-f95a-4165-a1d4-ac9640f72170 61 fields · synced Jun 19, 2026