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Metal Max+ Combi Laryngoscope with Batteries, Paediatric MAC 1

EUDAMEDFDA UDI

Class I (EU MDR)

Ref MMCB90MAC1

by PROACT Medical Ltd.

Identity

Trade Name
Metal Max+ Combi Laryngoscope with Batteries, Paediatric MAC 1 EUDAMED
PROACT Metal Max 90 FDA UDI
Generic Name
Laryngoscope blade, single-use FDA UDI
Device Name
Metal Max+ Combi Laryngoscopes with Pre-fitted Batteries EUDAMED
Metal Max+ Combi Laryngoscope with Batteries, Paediatric MAC 1 FDA UDI
Model / Reference
MMCB90MAC1 EUDAMEDFDA UDI
Description
Metal Max+ Combi Laryngoscope with Batteries, Paediatric MAC 1 FDA UDI

Identifiers

Catalog Number
MMCB90MAC1 FDA UDI
Primary DI / UDI-DI
25056094500017 EUDAMEDFDA UDI
Basic UDI-DI
50560945MMCB90EW EUDAMED
Unit of Use DI
15056094500010 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Metal Max+ Combi Laryngoscope with Batteries, Paediatric MAC 1 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

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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 d8c54509-7cf5-4d59-9aa0-c2d34613e805 61 fields · synced Jun 20, 2026
  • FDA UDI 8c79e37c-8f23-47ed-acd2-ea2d50d605d2 36 fields · synced May 30, 2026