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Slit Lamp microscope
EUDAMEDClass I (EU MDR)
Ref K5LModel K2, K2A, K5L, J3, J5L ,J9D, J8, J8D,P2Ref 2016TModel 2016, 2016T, 2016L, 2005M, 2005N, 2005T, 2005V, 2005S, M2101, N2101, T2101, V2101Ref J8Ref J9DRef J5L
Identity
- Trade Name
- Slit Lamp microscope EUDAMEDMicroscope EUDAMED
- Device Name
- Slit Lamp microscope EUDAMEDMicroscope EUDAMED
- Model / Reference
- K2, K2A, K5L, J3, J5L ,J9D, J8, J8D,P2 EUDAMEDK5L EUDAMED2016, 2016T, 2016L, 2005M, 2005N, 2005T, 2005V, 2005S, M2101, N2101, T2101, V2101 EUDAMED2016T EUDAMEDJ8 EUDAMEDJ9D EUDAMEDJ5L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226452187 EUDAMED06977226450640 EUDAMED06977226452224 EUDAMED06977226452217 EUDAMED06977226452200 EUDAMED
- Basic UDI-DI
- 697722645BTSLM013W EUDAMED697722645BTMS01RC EUDAMED
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMEDW0202050301 ELECTRON MICROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A 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
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Slit Lamp microscope by Nanjing Poweam Medical Co., Ltd — Class I — IVDR, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697722645BTSLM013W | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697722645BTSLM013W | Class I | Active |
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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 (5)
- EUDAMED 281f33d7-29da-4602-8b18-13bd5a3f2e3e 61 fields · synced Oct 6, 2026
- EUDAMED f68a6332-73e9-45eb-bfd6-04ae1ed61351 61 fields · synced May 17, 2026
- EUDAMED f422e5de-bb42-4037-9c45-e931a46d6b94 61 fields · synced May 18, 2026
- EUDAMED 4b30e368-5ebb-492e-95ad-a680e9e12b5a 61 fields · synced May 18, 2026
- EUDAMED 4bc59a8a-75b3-43ac-8dbd-4bff30b0c162 61 fields · synced May 19, 2026