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Blépharostat fil /plateaux

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 17537X10Model 17227X10

by Moria S.A.

Identity

Trade Name
Blépharostat fil /plateaux EUDAMED
ONE FDA UDI
Generic Name
Eyelid speculum, single-use FDA UDI
Device Name
Kratz wire speculum open blades EUDAMED
Model / Reference
17227X10 EUDAMED
17537X10 EUDAMED
ONE S-Wire speculum with tabs X10 FDA UDI

Identifiers

Catalog Number
17537X10 FDA UDI
Primary DI / UDI-DI
03700483621873 EUDAMEDFDA UDI
Basic UDI-DI
37004836Speculums2WZ EUDAMED
FDA Product Code
HNC FDA UDI
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
GMDN Term
Eyelid speculum, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
886.4350 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Blépharostat fil /plateaux by Moria 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
Moria S.A.
EUDAMED SRN
FR-MF-000000336

Sources (2)

  • EUDAMED 05bc04f5-610c-4182-86dc-3ccf130a1b43 61 fields · synced Jul 16, 2026
  • FDA UDI d4454884-8a91-442a-bb82-091d0ea0b588 33 fields · synced May 30, 2026