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Hydra II Green System Non-Contact Laryngoscope Handles, Stubby
EUDAMEDFDA UDIClass I (EU MDR)
Ref HYGSH293
Identity
- Trade Name
- Hydra II Green System Non-Contact Laryngoscope Handles, Stubby EUDAMEDPROACT Metal Max FDA UDI
- Generic Name
- Laryngoscope handle, reusable FDA UDI
- Device Name
- Hydra II Green System Laryngoscope Handles EUDAMEDHydra II Green System Non-Contact Laryngoscope Handles, Stubby FDA UDI
- Model / Reference
- HYGSH293 EUDAMEDFDA UDI
- Description
- Hydra II Green System Non-Contact Laryngoscope Handles, Stubby FDA UDI
Identifiers
- Catalog Number
- HYGSH293 FDA UDI
- Primary DI / UDI-DI
- 25056094502271 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945HYGSH2MY EUDAMED
- Direct Marketing DI
- 15056094502274 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
Hydra II Green System Non-Contact Laryngoscope Handles, Stubby by PROACT Medical Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50560945HYGSH2MY | 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 4c86b04b-f5ea-4d5d-8486-fbafdec9320a 61 fields · synced Oct 6, 2026
- FDA UDI e996e169-b006-4687-b6c0-501b7c2ba7bb 36 fields · synced May 30, 2026