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2zl
EUDAMEDFDA UDIClass I (EU MDR)
Ref B16001Ref 2ZLModel 2ZL、4ZL、30GL、700GL、MS1
by Takagi seiko
Identity
- Trade Name
- 2ZL EUDAMEDSlit Lamp Microscope 2ZL EUDAMEDTAKAGI FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Slit Lamp Microscope EUDAMED
- Model / Reference
- B16001 EUDAMED2ZL、4ZL、30GL、700GL、MS1 EUDAMED2ZL EUDAMEDSlitlamp Microscope 2ZL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560323641114 EUDAMEDFDA UDI
- Basic UDI-DI
- 4560323640018B EUDAMED
- 510(k) Number
- K152535 FDA UDI
- FDA Product Code
- HJO FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- Northern Ireland EUDAMEDSpain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
2zl by Takagi seiko — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4560323640018B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Takagi seiko
- EUDAMED SRN
- JP-MF-000008791
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED e7860001-bd04-4398-b3ff-9d56314c919e 61 fields · synced Jul 15, 2026
- FDA UDI 9ae48ccd-545d-4b20-b43d-bf6c68634e05 33 fields · synced May 30, 2026
- EUDAMED d988e03a-c1a6-4d17-b642-a29583326e70 61 fields · synced Jul 15, 2026