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Smoothline Green System Laryngoscope Blade, MIL 1
EUDAMEDFDA UDIClass I (EU MDR)
Ref H9031
Identity
- Trade Name
- Smoothline Green System Laryngoscope Blade, MIL 1 EUDAMEDPROACT Smoothline FDA UDI
- Generic Name
- Laryngoscope blade, reusable FDA UDI
- Device Name
- Smoothline Green System Laryngoscope Blades EUDAMEDSmoothline Green System Laryngoscope Blade, MIL 1 FDA UDI
- Model / Reference
- H9031 EUDAMEDFDA UDI
- Description
- Smoothline Green System Laryngoscope Blade, MIL 1 FDA UDI
Identifiers
- Catalog Number
- H9031 FDA UDI
- Primary DI / UDI-DI
- 25060179633811 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945SMOOTHLINESATINNZ EUDAMED
- Direct Marketing DI
- 15060179633814 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
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Smoothline Green System Laryngoscope Blade, MIL 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 | 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 dd0256a9-297d-4d4c-9abd-625295a45772 61 fields · synced Aug 5, 2026
- FDA UDI a11deeb0-2277-48d8-b2d0-be87ff31b464 36 fields · synced May 30, 2026