Identity
- Trade Name
- BLIS™ Bausch + Lomb Injector System EUDAMEDBausch + Lomb FDA UDI
- Generic Name
- Intraocular lens-insertion cartridge FDA UDI
- Device Name
- BLIS (or "Bausch and Lomb Injector System") EUDAMEDBLIS RE-USABLE HANDPIECE FDA UDI
- Model / Reference
- BLIS-R1 EUDAMEDFDA UDI
- Description
- BLIS RE-USABLE HANDPIECE FDA UDI
Identifiers
- Catalog Number
- BLIS-R1 FDA UDI
- Primary DI / UDI-DI
- 00757770520176 EUDAMEDFDA UDI
- Basic UDI-DI
- 0310119B1030Z7 EUDAMED
- FDA Product Code
- MSS FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Intraocular lens-insertion cartridge FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Intraocular lens-insertion cartridge
Bausch + Lomb by Bausch & Lomb Incorporated — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
Sources (2)
- FDA UDI f3999fd4-6fef-4cae-b78b-3c56bcc41043 34 fields · synced Jun 19, 2026
- EUDAMED cbcb9833-7814-4cc6-bde2-1e73bac8081f 61 fields · synced Jun 19, 2026