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HPC Green System Laryngoscope Blade, MAC 1
EUDAMEDFDA UDIClass I (EU MDR)
Ref HPCMAC1
Identity
- Trade Name
- HPC Green System Laryngoscope Blade, MAC 1 EUDAMEDPROACT HPC FDA UDI
- Generic Name
- Laryngoscope blade, single-use FDA UDI
- Device Name
- HPC Green System Laryngoscope Blades EUDAMEDHPC Green System Laryngoscope Blade, MAC 1 FDA UDI
- Model / Reference
- HPCMAC1 EUDAMEDFDA UDI
- Description
- HPC Green System Laryngoscope Blade, MAC 1 FDA UDI
Identifiers
- Catalog Number
- HPCMAC1 FDA UDI
- Primary DI / UDI-DI
- 25056094501540 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945HPCUY EUDAMED
- Unit of Use DI
- 15056094501543 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 Unsafe FDA UDI
HPC Green System Laryngoscope Blade, MAC 1 by PROACT Medical Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 50560945HPCUY | 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 af8976a6-a94c-40c9-9599-692b20f88f87 61 fields · synced Jul 11, 2026
- FDA UDI 66562ddc-e2d7-4caf-a99d-a4443e8d808d 36 fields · synced May 29, 2026