Identity
- Trade Name
- Synoptiscope EUDAMEDINAMI FDA UDI
- Generic Name
- Synoptophore FDA UDI
- Device Name
- STRABISMUS DEVICES EUDAMEDL-2510 INAMI Synoptiscope with standard slides, Haidinger Brush device FDA UDI
- Model / Reference
- L-2510HB EUDAMEDFDA UDI
- Description
- L-2510 INAMI Synoptiscope with standard slides, Haidinger Brush device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547451026280 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04547451026280 EUDAMED
- FDA Product Code
- HJQ FDA UDI
- EMDN Code
- Q0209 STRABISMUS DEVICES EUDAMED
- GMDN Term
- Synoptophore FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1870 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Synoptiscope by Inami & Co., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04547451026280 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inami & Co., Ltd.
- EUDAMED SRN
- JP-MF-000040062
- Authorised Representative
- WMDE B.V. NL-AR-000002062
Sources (2)
- EUDAMED 6817b830-77c1-40f4-8539-9d781730e96b 61 fields · synced Jun 17, 2026
- FDA UDI d0373c27-3010-47b6-af0e-0e5be3704818 33 fields · synced May 30, 2026