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Op-S8

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 68243114

by Optomic España S.a

Identity

Trade Name
OP-S8 EUDAMED
Optomic FDA UDI
Generic Name
ENT chair, electric FDA UDI
Device Name
Chair EUDAMED
Model / Reference
68243114 EUDAMED
OP-S8 CHAIR FDA UDI

Identifiers

Primary DI / UDI-DI
08436041580379 EUDAMEDFDA UDI
Basic UDI-DI
84360415810292Y EUDAMED
FDA Product Code
GBB FDA UDI
EMDN Code
V08020101 GENERIC USE ELECTRIC MEDICAL CHAIRS EUDAMED
GMDN Term
ENT chair, electric FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4960 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-S8 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 fbd55c83-e609-47f6-967c-73f6e9419e01 61 fields · synced Jun 19, 2026
  • FDA UDI 3ae74e05-9c7a-43e9-a409-78b66277b80e 32 fields · synced May 30, 2026