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Howell
EUDAMEDClass I (EU MDR)
Ref HE-L700/500Model 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-L700/500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974445421031 EUDAMED
- Basic UDI-DI
- 697444542HE700/500JK EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Howell by Harbin Howell Medical Apparatus and Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 2fbb53cf-9551-4ca0-a001-4da490dec92c 61 fields · synced Jun 19, 2026