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Op-C16

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 8263307

by Optomic España S.a

Identity

Trade Name
OP-C16 EUDAMED
Optomic FDA UDI
Generic Name
ENT surgical microscope FDA UDI
Device Name
Microscope EUDAMED
Model / Reference
8263307 EUDAMED
OP-C16 Microscope FDA UDI

Identifiers

Primary DI / UDI-DI
08436041580065 EUDAMEDFDA UDI
Basic UDI-DI
84360415801052G EUDAMED
FDA Product Code
HRM FDA UDI
EMDN Code
Z12011101 OPERATIVE MICROSCOPES EUDAMED
GMDN Term
ENT surgical microscope FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4700 FDA UDI
Market of Registration
Spain 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

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

No

FDA UDI

Op-C16 by Optomic España S.a — 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

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Manufacturer

Manufacturer
Optomic España S.a
EUDAMED SRN
ES-MF-000003235

Sources (2)

  • EUDAMED fdfedd19-1dcd-41e0-953a-45a9829f6a83 61 fields · synced Jun 19, 2026
  • FDA UDI 726dce3b-59d8-40a8-b299-ef83103d474b 32 fields · synced May 30, 2026