Identity
- Trade Name
- ME-CHECK FDA UDI
- Generic Name
- Multi-purpose digital medical camera lens, extraocular FDA UDI
- Model / Reference
- ME-CHECK FDA UDI
Identifiers
- Catalog Number
- ME-CHECK FDA UDI
- Primary DI / UDI-DI
- 08056389700002 FDA UDI
- FDA Product Code
- PJZ FDA UDI
- GMDN Term
- Multi-purpose digital medical camera lens, extraocular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-purpose digital medical camera lens, extraocular
Me-Check by Espansione Marketing Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose digital medical camera lens, extraocular.
- ME-CHECK H — ESPANSIONE MARKETING SPA · Class II
- ME-CHECK 4 — ESPANSIONE MARKETING SPA · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Espansione Marketing Spa
Sources (2)
- FDA UDI e20aee5c-d2c7-46a8-a2d1-6c262f446375 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026