Sterrad

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10033-004

by Advanced Sterilization Products Services Inc.

Identity

Trade Name: STERRAD NX™ Sterilization System with ALLClear™ Technology EUDAMED
STERRAD FDA UDI
Generic Name: Plasma sterilizer FDA UDI
Device Name: STERRAD NX™ Sterilization System with ALLClear™ Technology EUDAMED
STERRAD NX Sterilization System with ALLClear Technology FDA UDI
Model / Reference: 10033-004 EUDAMEDFDA UDI
Description: STERRAD NX Sterilization System with ALLClear Technology FDA UDI

Identifiers

Catalog Number: 10033-004 FDA UDI
Primary DI / UDI-DI: 10705037048656 EUDAMEDFDA UDI
Basic UDI-DI: 0705037A040000000000004MF EUDAMED
Direct Marketing DI: 10705037048656 EUDAMED
510(k) Number: K160818 FDA UDI
K220404 FDA UDI
FDA Product Code: MLR FDA UDI
EMDN Code: Z12011309 PLASMA STERILISERS EUDAMED
GMDN Term: Plasma sterilizer 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Plasma sterilizer

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 Plasma sterilizer.

STERILINK™ — Plasmapp Co., Ltd. · Class II
H2O2 Low Temperature Plasma Sterilizer — Shinva Medical Instrument Co., Ltd. · Class IIa
ERYİĞİT — ERYİĞİT ENDÜSTRİYEL MAKİNA VE TIBBİ CİHAZLAR İMALAT İTHALAT İHRACAT İNŞAAT TİCARET ANONİM ŞİRKETİ · Class IIb
P50 — SMS Sp. z o.o. · Class IIa
STERILINK™ — Plasmapp Co., Ltd. · Class II
H2O2 Low Temperature Plasma Sterilizer — Shinva Medical Instrument Co., Ltd. · Class IIa
H2O2 Low Temperature Plasma Sterilizer — Shinva Medical Instrument Co., Ltd. · Class IIa
P150DD — SMS Sp. z o.o. · Class IIb

Cleared under the same submission

K220404 also covers:

Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.

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 2ee39540-aaa1-4bed-a7ab-e33db422af1c 37 fields · synced Jun 19, 2026
EUDAMED c550ecab-0204-4bf2-bdcc-63bcf3fc0d40 61 fields · synced Jun 19, 2026