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ORMR-2X Reichel-Mainster 2x Retina Laser Lens

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 7577

by Ocular Instruments Inc.

Identity

Trade Name
ORMR-2X Reichel-Mainster 2x Retina Laser Lens EUDAMED
Reichel-Mainster 2x Retina Laser Lens FDA UDI
Generic Name
Laser lens, ophthalmic, surgical FDA UDI
Device Name
Contact Ophthalmic EUDAMED
Model / Reference
7577 EUDAMED
ORMR-2X FDA UDI

Identifiers

Primary DI / UDI-DI
00630238075770 EUDAMEDFDA UDI
Basic UDI-DI
06302381262637 EUDAMED
Direct Marketing DI
00630238075794 EUDAMED
510(k) Number
K863911 FDA UDI
FDA Product Code
HJK FDA UDI
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
GMDN Term
Laser lens, ophthalmic, surgical FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
886.1385 FDA UDI
Market of Registration
Austria 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

ORMR-2X Reichel-Mainster 2x Retina Laser Lens by Ocular Instruments, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Ocular Instruments Inc.
EUDAMED SRN
US-MF-000007216
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED d03161e2-7bb9-4203-9944-0123d3c7e88a 61 fields · synced Oct 6, 2026
  • FDA UDI 2f4bccbf-b3a4-4591-a032-970307419fb6 33 fields · synced May 30, 2026
  • FDA 510(k) K863911 1 fields · synced May 18, 2026