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Howell
EUDAMEDClass I (EU MDR)
Ref HE-K4Model HE-L500、HE-L600、HE-L700、HE-L700/500、HE-L500/500、HE-L600/600、HE-L700/700、HE-L5+3、HE-L5、HE-L3、HE-K9/4、HE-K4 、HE-K9、HE-L4、HE-K5
by Harbin Howell Medical Apparatus and Instruments Co., Ltd.
Identity
- Trade Name
- HOWELL EUDAMED
- Device Name
- Shadowless Operating Lamp EUDAMED
- Model / Reference
- HE-L500、HE-L600、HE-L700、HE-L700/500、HE-L500/500、HE-L600/600、HE-L700/700、HE-L5+3、HE-L5、HE-L3、HE-K9/4、HE-K4 、HE-K9、HE-L4、HE-K5 EUDAMEDHE-K4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974445421116 EUDAMED
- Basic UDI-DI
- 697444542HE700/500JK EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Howell by Harbin Howell Medical Apparatus and Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697444542HE700/500JK | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000025141
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 946c7acc-f87c-4f95-8b03-ccaa32de395e 61 fields · synced Jun 19, 2026