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S13001

by Ophmed Co., Ltd.

Ref S13001

S13001 is a Class IIa device made by Ophmed Co., Ltd., registered in EUDAMED on 14 Mar 2024 (Basic UDI-DI B-06974482530338), active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06974482530338 Basic UDI-DI 06974482530338UDI-DIDate14 Mar 2024RegisteredStatusActive
European UnionCE/MDD NumberB-06974482530338 Basic UDI-DI 06974482530338UDI-DIDate14 Mar 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device name
Disposable Ophthalmic Scissors
Model / reference
S13001
Primary DI / UDI-DI
06974482530338
Basic UDI-DI
B-06974482530338, 697448253S13000AA
EMDN code
Q021103 Ophthalmic surgery scissors, single-use
Device class
Class IIa
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000032262
Authorised representative
Caretechion GmbH DE-AR-000005946

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Ophmed Co., Ltd.

See all devices from Ophmed Co., Ltd. →

Properties

  • Supplied sterile
  • Sterilise before use
Other properties (12, all answered No)