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Mucolyse (Inner-100 mg)

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref PL.701

by Pro-Lab, Incorporated

Identity

Trade Name
Mucolyse EUDAMED
Mucolyse (Inner-100 mg) FDA UDI
Generic Name
Sputum liquefaction/decontamination reagent IVD FDA UDI
Device Name
Mucolyse EUDAMED
PRO-LAB Mucolyse is a sputum liquefying agent used to digest and thin out the sputum, thus enhancing the isolation of organisms responsible for chronic lung disease FDA UDI
Model / Reference
PL.701 EUDAMEDFDA UDI
Description
PRO-LAB Mucolyse is a sputum liquefying agent used to digest and thin out the sputum, thus enhancing the isolation of organisms responsible for chronic lung disease FDA UDI

Identifiers

Catalog Number
PL.701 FDA UDI
Primary DI / UDI-DI
10628429001001 EUDAMEDFDA UDI
Basic UDI-DI
62842900100PU EUDAMED
Direct Marketing DI
10628429001001 EUDAMED
FDA Product Code
JSK FDA UDI
EMDN Code
W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
GMDN Term
Sputum liquefaction/decontamination reagent IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
866.2450 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

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

Category: Sputum liquefaction/decontamination reagent IVD

Mucolyse (Inner-100 mg) by Pro-Lab, Incorporated — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Sputum liquefaction/decontamination reagent IVD.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (2)

  • FDA UDI f272d059-8daa-43b2-b276-d5df9ab39b03 34 fields · synced Jun 19, 2026
  • EUDAMED c8689a84-f4c8-4c62-88b0-bb234509cd7d 61 fields · synced Jun 19, 2026