ATMOS S 61 Servant instruments XXL

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 532.0400.0Model Cabinets, Instrument

by ATMOS MedizinTechnik GmbH & Co. KG

Identity

Trade Name: ATMOS S 61 Servant instruments XXL EUDAMED
ATMOS FDA UDI
Generic Name: ENT cabinet FDA UDI
Device Name: The device is a cabinet for the storage and management of instruments, diagnostic devices or visualisation devices for ENT specialists. The user can assemble the workplace with options and accessories according to his personal requirements. The device is used in clinics or ENT offices. FDA UDI
Model / Reference: Cabinets, Instrument EUDAMED
532.0400.0 EUDAMED
S 61 Servant instruments XXL FDA UDI
Description: The device is a cabinet for the storage and management of instruments, diagnostic devices or visualisation devices for ENT specialists. The user can assemble the workplace with options and accessories according to his personal requirements. The device is used in clinics or ENT offices. FDA UDI

Identifiers

Primary DI / UDI-DI: 04250365174984 EUDAMEDFDA UDI
Basic UDI-DI: 42503651ENTUnitS61SERinXP EUDAMED
Direct Marketing DI: 04250365174984 EUDAMED
FDA Product Code: ETF FDA UDI
EMDN Code: Z121402 ENT TREATMENT UNITS EUDAMED
GMDN Term: ENT cabinet FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 874.5300 FDA UDI
Market of Registration: Germany 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ENT examination/treatment system

ATMOS S 61 Servant instruments XXL by ATMOS MedizinTechnik GmbH & Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT examination/treatment system.

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Extension module, 1 handle, ri-former® — Rudolf Riester GmbH & Co. KG · Class II
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Optomic — OPTOMIC ESPAÑA SA · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	42503651ENTUnitS61SERinXP	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: ATMOS MedizinTechnik GmbH & Co. KG
EUDAMED SRN: DE-MF-000005570

Sources (2)

EUDAMED 7a69a477-2811-40fd-8933-e5bf5af39015 61 fields · synced Jul 20, 2026
FDA UDI 0b1824bc-9f0b-41cc-a7ec-c6529e3b6e72 33 fields · synced May 30, 2026