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Thornhill Research Inc.

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 127406

by Thornhill Research Inc

Identity

Trade Name
Thornhill Research Inc. EUDAMED
MOVES FDA UDI
Generic Name
Transport electric ventilator FDA UDI
Device Name
MOVES® SLC™ Nafion Tube [Kit, MOVES SLC, Nafion Tube] EUDAMED
Hose, 0.04" x 0.0625", Nafion w/ Label FDA UDI
Model / Reference
127406 EUDAMED
124241 FDA UDI
Description
Hose, 0.04" x 0.0625", Nafion w/ Label FDA UDI

Identifiers

Primary DI / UDI-DI
10807141000084 EUDAMEDFDA UDI
Basic UDI-DI
B-10807141000084 EUDAMED
510(k) Number
K093261 FDA UDI
FDA Product Code
BTL FDA UDI
EMDN Code
R020108 RESPIRATORY GAS MONITORING AND SAMPLING CIRCUITS AND KITS EUDAMED
GMDN Term
Transport electric ventilator FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
868.5925 FDA UDI
Market of Registration
Netherlands 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Thornhill Research Inc. by Thornhill Research Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
CA-MF-000039470
Authorised Representative
Freyr Regulatory GmbH DE-AR-000047121

Sources (2)

  • EUDAMED b64a3006-1cb2-4d70-9739-c5bdf2075da8 61 fields · synced Jul 12, 2026
  • FDA UDI dead28ca-e6d6-4d3e-90db-5da7249c9447 35 fields · synced May 30, 2026