Sterrad

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10144

by Advanced Sterilization Products Services Inc.

Identity

Trade Name: STERRAD™ 100NX Cassette EUDAMED
Sterrad FDA UDI
Generic Name: Hydrogen peroxide device sterilant FDA UDI
Device Name: STERRAD™ 100NX Cassette EUDAMED
Sterrad 100 NX Cassette FDA UDI
Model / Reference: 10144 EUDAMEDFDA UDI
Description: Sterrad 100 NX Cassette FDA UDI

Identifiers

Catalog Number: 10144 FDA UDI
Primary DI / UDI-DI: 10705037014903 EUDAMEDFDA UDI
Basic UDI-DI: 0705037A140000000000014NZ EUDAMED
510(k) Number: K071385 FDA UDI
K092622 FDA UDI
K111377 FDA UDI
K142454 FDA UDI
K234082 FDA UDI
FDA Product Code: MLR FDA UDI
EMDN Code: S900101 HYDROGEN PEROXIDE CARTRIDGES EUDAMED
GMDN Term: Hydrogen peroxide device sterilant FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 880.6860 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hydrogen peroxide device sterilant

Sterrad by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Hydrogen peroxide device sterilant.

Liquid Ultra — CROSSTEX INTERNATIONAL, INC. · Class I
Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
125-280 Solution™ for STERIZONE VP4 Sterilizer — Tso3, Inc. · Class II
VAPROX — STERIS CORPORATION · Class II
SPOROX® II — Sultan Healthcare Inc · Class II
VAPROX — STERIS CORPORATION · Class II
SPOROX® — Sultan Healthcare Inc · Class II
Compliance — METREX RESEARCH · Class II

Cleared under the same submission

K071385 also covers:

K092622 also covers:

K111377 also covers:

K142454 also covers:

K234082 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Advanced Sterilization Products Services Inc.

Sources (2)

FDA UDI d9eeb363-fc07-415c-95e3-6ee98b62a898 37 fields · synced Jun 18, 2026
EUDAMED 497044d4-3871-4a2e-9816-64f053d2ce82 61 fields · synced Jun 18, 2026