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Miele

FDA UDI

Class II (US FDA UDI)

by Miele & Cie. KG

Identity

Trade Name
Miele FDA UDI
Generic Name
Surgical utensil washer/disinfector FDA UDI
Device Name
Washer-Disinfector FDA UDI
Model / Reference
PG 8582 FDA UDI
Description
Washer-Disinfector FDA UDI

Identifiers

Primary DI / UDI-DI
04002515642337 FDA UDI
FDA Product Code
MEC FDA UDI
GMDN Term
Surgical utensil washer/disinfector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6992 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical utensil washer/disinfector

Miele by Miele & Cie. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical utensil washer/disinfector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Miele & Cie. KG

Sources (1)

  • FDA UDI 711057b6-7ed7-4180-ac16-2bb01830a0f4 33 fields · synced May 30, 2026