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Metal Max 100 Conventional Laryngoscope Blade, MAC 2
EUDAMEDFDA UDIClass I (EU MDR)
Ref MMCV100MAC2
Identity
- Trade Name
- Metal Max 100 Conventional Laryngoscope Blade, MAC 2 EUDAMEDPROACT Metal Max 100 FDA UDI
- Generic Name
- Laryngoscope blade, single-use FDA UDI
- Device Name
- Metal Max 100 Conventional Laryngoscope Blades EUDAMEDMetal Max 100 Conventional Laryngoscope Blade, MAC 2 FDA UDI
- Model / Reference
- MMCV100MAC2 EUDAMEDFDA UDI
- Description
- Metal Max 100 Conventional Laryngoscope Blade, MAC 2 FDA UDI
Identifiers
- Catalog Number
- MMCV100MAC2 FDA UDI
- Primary DI / UDI-DI
- 25056094500543 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560945MMCV100K8 EUDAMED
- Unit of Use DI
- 15056094500546 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
Metal Max 100 Conventional 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 | 50560945MMCV100K8 | 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 8442f44b-4be9-4acf-955e-1b5546965bc8 61 fields · synced Jul 10, 2026
- FDA UDI 6fe2b17b-d93c-4e86-919b-5695bc7eea7b 36 fields · synced May 29, 2026