Identity
- Trade Name
- Laryngoscope Blade, Reusable EUDAMED
- Device Name
- Laryngoscope Blade, Reusable EUDAMED
- Model / Reference
- FMC-003-3010-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003352356 EUDAMED
- Basic UDI-DI
- 8964003352HM015B EUDAMED
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Laryngoscope blade, reusable
Laryngoscope Blade, Reusable by Haymed Instruments — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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- Sklar® — Sklar Corporation · 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 | 8964003352HM015B | Class I | Active |
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Manufacturer
- Manufacturer
- Haymed Instruments
- EUDAMED SRN
- PK-MF-000012992
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 7d3a7efd-f39c-43ce-9aed-a37a42d7f87e 61 fields · synced Jul 11, 2026