← Back to catalogue
MR Conditional HPC Green System Laryngoscope Blade, MAC 2
EUDAMEDFDA UDIClass I (EU MDR)
Ref MRHPCMAC2
Identity
- Trade Name
- MR Conditional HPC Green System Laryngoscope Blade, MAC 2 EUDAMEDPROACT MR Conditional FDA UDI
- Generic Name
- Laryngoscope blade, single-use FDA UDI
- Device Name
- MR Conditional HPC Green System Laryngoscope Blades EUDAMEDMR Conditional HPC Green System Laryngoscope Blade, MAC 2 FDA UDI
- Model / Reference
- MRHPCMAC2 EUDAMEDFDA UDI
- Description
- MR Conditional HPC Green System Laryngoscope Blade, MAC 2 FDA UDI
Identifiers
- Catalog Number
- MRHPCMAC2 FDA UDI
- Primary DI / UDI-DI
- 25060179635181 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945MRHPCMR EUDAMED
- Unit of Use DI
- 15060179635184 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- R9002 LARYNGOSCOPE BLADES, SINGLE-USE EUDAMED
- GMDN Term
- Laryngoscope blade, 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 Conditional FDA UDI
MR Conditional HPC Green System Laryngoscope Blade, MAC 2 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 | 50560945MRHPCMR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PROACT Medical Ltd.
- EUDAMED SRN
- GB-MF-000006294
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (2)
- EUDAMED 866d5e9d-d1c9-4625-b255-82d963c6c970 61 fields · synced Jun 18, 2026
- FDA UDI 3bfc19a2-b18d-416c-acbb-24f350423c28 36 fields · synced May 30, 2026