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Metal Max Green System Laryngoscope Handle, Paediatric
EUDAMEDFDA UDIClass I (EU MDR)
Ref MMGSH002
Identity
- Trade Name
- Metal Max Green System Laryngoscope Handle, Paediatric EUDAMEDPROACT Metal Max FDA UDI
- Generic Name
- Laryngoscope handle, single-use FDA UDI
- Device Name
- Metal Max Green System Laryngoscope Handles without Batteries EUDAMEDMetal Max Green System Laryngoscope Handle, Paediatric FDA UDI
- Model / Reference
- MMGSH002 EUDAMEDFDA UDI
- Description
- Metal Max Green System Laryngoscope Handle, Paediatric FDA UDI
Identifiers
- Catalog Number
- MMGSH002 FDA UDI
- Primary DI / UDI-DI
- 25056094500420 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945MMGSHM4 EUDAMED
- Unit of Use DI
- 15056094500423 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
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Laryngoscope blade, reusable
Metal Max Green System Laryngoscope Handle, Paediatric by PROACT Medical Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Laryngoscope blade, reusable.
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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 | 50560945MMGSHM4 | 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 481cd371-5b55-4f4d-87dc-8af40e1d63e7 61 fields · synced Jun 19, 2026
- FDA UDI 82522cd0-5372-46ce-9a7f-f1da5e02e3a7 36 fields · synced May 30, 2026