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Hydra Conventional Laryngoscope Handle, Adult
EUDAMEDFDA UDIClass I (EU MDR)
Ref HYCVH001
Identity
- Trade Name
- Hydra Conventional Laryngoscope Handle, Adult EUDAMEDPROACT Metal Max FDA UDI
- Generic Name
- Laryngoscope handle, reusable FDA UDI
- Device Name
- Hydra Conventional Laryngoscope Handles EUDAMEDHydra Conventional Laryngoscope Handle, Adult FDA UDI
- Model / Reference
- HYCVH001 EUDAMEDFDA UDI
- Description
- Hydra Conventional Laryngoscope Handle, Adult FDA UDI
Identifiers
- Catalog Number
- HYCVH001 FDA UDI
- Primary DI / UDI-DI
- 25056094500277 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945HYCVHMN EUDAMED
- Direct Marketing DI
- 15056094500270 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Laryngoscope blade, reusable
Hydra Conventional Laryngoscope Handle, Adult 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
European Union Active
CE/MDR
United States Pending data
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 c6c96b34-0672-4929-9269-d21e0b5cbd99 61 fields · synced Jul 13, 2026
- FDA UDI 08ccf241-c48e-461f-9d19-31189c4e8ca0 36 fields · synced May 30, 2026