Smoothline Green System Laryngoscope Blade, MAC 2
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Smoothline Green System Laryngoscope Blade, MAC 2 EUDAMEDPROACT Smoothline FDA UDI
- Generic Name
- Laryngoscope blade, reusable FDA UDI
- Device Name
- Smoothline Green System Laryngoscope Blades EUDAMEDSmoothline Green System Laryngoscope Blade, MAC 2 FDA UDI
- Model / Reference
- H9022 EUDAMEDFDA UDI
- Description
- Smoothline Green System Laryngoscope Blade, MAC 2 FDA UDI
Identifiers
- Catalog Number
- H9022 FDA UDI
- Primary DI / UDI-DI
- 25060179633774 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945SMOOTHLINESATINNZ EUDAMED
- Direct Marketing DI
- 15060179633777 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Laryngoscope blade, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Laryngoscope blade, reusable
Smoothline Green System Laryngoscope Blade, MAC 2 by PROACT Medical Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 50560945SMOOTHLINESATINNZ | 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 de490a2a-6bea-4086-9524-fbd8a5e2861c 61 fields · synced Jun 18, 2026
- FDA UDI f12dfde3-d9b6-4f65-af78-2e37735bda0b 36 fields · synced May 30, 2026