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Operating Lamp

EUDAMED

Class I (EU MDR)

Ref 600-IIWModel LED.DTR78, LED.DTR78/DTR78, LED.D78, LED.D78/D78, LED.DT61/DT61, LED.DT61, LED.STZ5, LED.STZ5/STZ5, LED.STZ4, LED.STZ4/STZ4, LED.SZ4, LED.SZ4/SZ4, LED.MSTZ5, LED.MSTZ4, LED.MSZ4, LED.MD61, 01L.IILEDTR, 01L.IILED

by Nanjing Poweam Medical Co., Ltd

Identity

Device Name
Operating Lamp EUDAMED
Model / Reference
LED.DTR78, LED.DTR78/DTR78, LED.D78, LED.D78/D78, LED.DT61/DT61, LED.DT61, LED.STZ5, LED.STZ5/STZ5, LED.STZ4, LED.STZ4/STZ4, LED.SZ4, LED.SZ4/SZ4, LED.MSTZ5, LED.MSTZ4, LED.MSZ4, LED.MD61, 01L.IILEDTR, 01L.IILED EUDAMED
600-IIW EUDAMED

Identifiers

Primary DI / UDI-DI
06977226452750 EUDAMED
Basic UDI-DI
697722645BTOL01QP EUDAMED
EMDN Code
Z12010701 FIXED SCIALYTIC LAMPS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Operating room light system

Operating Lamp by Nanjing Poweam Medical Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Operating room light system.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Nanjing Poweam Medical Co., Ltd
EUDAMED SRN
CN-MF-000040207
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 81efd850-3c2b-4065-9c9b-9ba4de738262 61 fields · synced Jun 19, 2026