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Autoclave Indicator Tape +1 more model

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241036Ref N/AModel 19mm*30m 19mm*38m 19mm*50m 25mm*50m 18mm*50m 24mm*50m 12mm*50m 12.5mm*50m

by Jiangmen New Era External Use Drug Co., Ltd

Identity

Device Name
Autoclave Indicator Tape EUDAMED
Model / Reference
19mm*30m 19mm*38m 19mm*50m 25mm*50m 18mm*50m 24mm*50m 12mm*50m 12.5mm*50m EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06944270104294 EUDAMED
Basic UDI-DI
69442701M111L7 EUDAMED
510(k) Number
K241036 FDA 510(k)
FDA Product Code
JOJ FDA 510(k)
EMDN Code
S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Models / Variants
Autoclave Indicator Tape FDA 510(k)EUDAMED
EO Indicator Tape FDA 510(k)EUDAMED

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2800 FDA 510(k)
Regulation Number
880.2800 FDA 510(k)
Market of Registration
Netherlands EUDAMED
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Autoclave Indicator Tape +1 more model by Jiangmen New Era External Use Drug Co., Ltd — Class II — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — 2 models

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jiangmen New Era External Use Drug Co., Ltd
FDA Applicant
Jiangmen New Era External Use Drug Co., Ltd.

Sources (3)

  • FDA 510(k) K241036 24 fields · synced Jul 28, 2026
  • EUDAMED fc313abe-0ce8-4649-abe6-a1df68c3ad5f-1 61 fields · synced Jul 28, 2026
  • EUDAMED fc313abe-0ce8-4649-abe6-a1df68c3ad5f-2 61 fields · synced Jul 28, 2026