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Immeging
EUDAMEDClass I (EU MDR)
Ref RJ8604003Ref RJ8604004Ref RJ8603002Ref RJ8603029Ref RJ8603047
Identity
- Trade Name
- Immeging EUDAMED
- Device Name
- LED Light Source EUDAMED4K Camera System EUDAMED
- Model / Reference
- RJ8604003 EUDAMEDRJ8604004 EUDAMEDRJ8603002 EUDAMEDRJ8603029 EUDAMEDRJ8603047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975218730589 EUDAMED06975218730619 EUDAMED06975218730176 EUDAMED06975218730565 EUDAMED06975218730572 EUDAMED
- Basic UDI-DI
- 697521873RJES2100401LV EUDAMED697521873RJES2100400LT EUDAMED
- Direct Marketing DI
- 06975218730589 EUDAMED06975218730619 EUDAMED06975218730176 EUDAMED06975218730565 EUDAMED06975218730572 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMEDZ12020405 SURGICAL CAMERAS 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: Endoscopic light source unit, line-powered
Immeging by Hangzhou Rejoin Medical Technology 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 | 697521873RJES2100401LV | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Rejoin Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000036490
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED f24eb437-3f97-4215-8aa7-574afac529aa 61 fields · synced Jul 18, 2026
- EUDAMED 035dbde9-e10a-4232-a49d-0695dbd4f4a4 61 fields · synced May 11, 2026
- EUDAMED fbef8b02-d6d8-4e35-917b-9e9353366351 61 fields · synced May 17, 2026
- EUDAMED e679ddbf-5095-4344-9553-b60383fd6ba8 61 fields · synced May 17, 2026
- EUDAMED 4ffc64d4-331b-4d1f-90e7-d6c237770a73 61 fields · synced May 17, 2026