MR Conditional Metal Max+ Green System Laryngoscope Handle with Re-usable Batte…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- MR Conditional Metal Max+ Green System Laryngoscope Handle with Re-usable Batteries, Adult EUDAMEDPROACT MR Conditional FDA UDI
- Generic Name
- Laryngoscope handle, single-use FDA UDI
- Device Name
- MR Conditional Metal Max+ Green System Laryngoscope Handles with Re-usable Batteries EUDAMEDMR Conditional Metal Max+ Green System Laryngoscope Handle with Re-usable Batteries, Adult FDA UDI
- Model / Reference
- MRGSHB01 EUDAMEDFDA UDI
- Description
- MR Conditional Metal Max+ Green System Laryngoscope Handle with Re-usable Batteries, Adult FDA UDI
Identifiers
- Catalog Number
- MRGSHB01 FDA UDI
- Primary DI / UDI-DI
- 25060179635167 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945MRGSHBNJ EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Laryngoscope handle, single-use 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
Yes
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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Laryngoscope blade, reusable
MR Conditional Metal Max+ Green System Laryngoscope Handle with Re-usable Batte… by PROACT Medical Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 50560945MRGSHBNJ | 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 f7f39589-4875-4cd7-893d-665c232349fe 61 fields · synced Jun 18, 2026
- FDA UDI c8fe4993-e33a-4f0b-a554-d202e1f93a97 36 fields · synced May 30, 2026