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Op-C16

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 19503014

by Optomic España S.a

Identity

Trade Name
OP-C16 EUDAMED
Optomic FDA UDI
Generic Name
Colposcope FDA UDI
Device Name
Colposcope EUDAMED
Model / Reference
19503014 EUDAMED
OP-C16 COLPOSCOPE (45) FDA UDI

Identifiers

Primary DI / UDI-DI
08436041580096 EUDAMEDFDA UDI
Basic UDI-DI
84360415801112B EUDAMED
FDA Product Code
PTZ FDA UDI
EMDN Code
Z12020703 COLPOSCOPES EUDAMED
GMDN Term
Colposcope FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
884.1630 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 438e10ea-1620-4ef5-8992-434f2fe20027 61 fields · synced Jul 28, 2026
  • FDA UDI 226ce16b-fc58-4f63-b003-23f5ef6ff7cc 32 fields · synced May 30, 2026