Hydra Conventional Laryngoscope Handle, Paediatric
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Hydra Conventional Laryngoscope Handle, Paediatric EUDAMEDPROACT Metal Max FDA UDI
- Generic Name
- Laryngoscope handle, reusable FDA UDI
- Device Name
- Hydra Conventional Laryngoscope Handles EUDAMEDHydra Conventional Laryngoscope Handle, Paediatric FDA UDI
- Model / Reference
- HYCVH002 EUDAMEDFDA UDI
- Description
- Hydra Conventional Laryngoscope Handle, Paediatric FDA UDI
Identifiers
- Catalog Number
- HYCVH002 FDA UDI
- Primary DI / UDI-DI
- 25056094500284 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945HYCVHMN EUDAMED
- Direct Marketing DI
- 15056094500287 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Laryngoscope handle, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Laryngoscope blade, reusable
Hydra Conventional Laryngoscope Handle, Paediatric by PROACT Medical Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50560945HYCVHMN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PROACT Medical Ltd.
- EUDAMED SRN
- GB-MF-000006294
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (2)
- EUDAMED 64fc0b79-d76b-4802-9ecc-d9ad10f03c80 61 fields · synced Jun 19, 2026
- FDA UDI d2e1496c-40be-49c0-ab5c-22d1bc6ee33e 36 fields · synced May 30, 2026