Sterrad

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10104-006Model 10104

by Advanced Sterilization Products Services Inc.

Identity

Trade Name: STERRAD™ 100NX, Systems with ALLClear™ Technology, 2 Door EUDAMED
STERRAD FDA UDI
Generic Name: Plasma sterilizer FDA UDI
Device Name: STERRAD™ 100NX Sterilizer with ALLClear™ Technology EUDAMED
STERRAD 100NX, Systems with ALLClear Technology, 2 Doors FDA UDI
Model / Reference: 10104-006 EUDAMEDFDA UDI
10104 EUDAMED
Description: STERRAD 100NX, Systems with ALLClear Technology, 2 Doors FDA UDI

Identifiers

Catalog Number: 10104-006 FDA UDI
Primary DI / UDI-DI: 10705037048687 EUDAMEDFDA UDI
Basic UDI-DI: 0705037A050000000000005NU EUDAMED
Direct Marketing DI: 10705037048687 EUDAMED
510(k) Number: K160903 FDA UDI
K212174 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

K160903 also covers:

K212174 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Advanced Sterilization Products Services Inc.

Sources (2)

FDA UDI 8342b14d-b4fe-4c97-91a1-60f7f002ad77 37 fields · synced Jun 19, 2026
EUDAMED 42ed952b-f856-44b4-a18b-129f58002b7a 61 fields · synced Jun 19, 2026