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Slit Lamp microscope
EUDAMEDClass I (EU MDR)
Ref P2Model K2, K2A, K5L, J3, J5L ,J9D, J8, J8D,P2
Identity
- Trade Name
- Slit Lamp microscope EUDAMED
- Device Name
- Slit Lamp microscope EUDAMED
- Model / Reference
- K2, K2A, K5L, J3, J5L ,J9D, J8, J8D,P2 EUDAMEDP2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226452248 EUDAMED
- Basic UDI-DI
- 697722645BTSLM013W EUDAMED
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
Classification
- Device Class
- Class I 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
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Slit Lamp microscope by Nanjing Poweam Medical 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 | 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 (1)
- EUDAMED ed23001f-3d17-43ba-ae0a-c8d88c1d61a6 61 fields · synced Jun 19, 2026