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Howell
EUDAMEDClass I (EU MDR)
Ref HE-L5+3Model 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-L5+3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974445421079 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
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 c0acf244-a30d-47b3-88ff-e18a7d2aff3c 61 fields · synced Jun 19, 2026