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Scoreflex NC Scoring PTCA Catheter 635-104-1U

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Ref 630-104-1J, 620-204-1J, 620-154-1J, 617-204-1J, 635-204-1J, 620-104-1J, 627-204-1J, 625-154-1J, 640-104-1J, 630-154-1J, 617-104-1J, 625-204-1J

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06934955936166 UDI-DI Date16 Feb 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06934955936166 Basic UDI-DI Date23 Dec 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Scoreflex NC EUDAMED
Scoreflex NC Scoring PTCA Catheter GUDID
Generic Name
Coronary angioplasty balloon catheter, cutting/scoring
Device Name
Scoreflex NC Coronary Dilatation Catheter
Model / Reference
630-104-1J EUDAMED
620-204-1J EUDAMED
620-154-1J EUDAMED
617-204-1J EUDAMED
635-204-1J EUDAMED
620-104-1J EUDAMED
627-204-1J EUDAMED
625-154-1J EUDAMED
640-104-1J EUDAMED
630-154-1J EUDAMED
617-104-1J EUDAMED
625-204-1J EUDAMED
635-104-1U GUDID
Primary DI / UDI-DI
06934955936166 EUDAMED
06934955936067 EUDAMED
06934955936050 EUDAMED
06934955936036 EUDAMED
06934955936210 EUDAMED
06934955936043 EUDAMED
06934955936159 EUDAMED
06934955936111 EUDAMED
06934955936227 EUDAMED
06934955936173 EUDAMED
06934955936012 EUDAMED
06934955936128 EUDAMED
06934955936432 GUDID
Basic UDI-DI
B-06934955936166, B-06934955936067, B-06934955936050, B-06934955936036, B-06934955936210, B-06934955936043, B-06934955936159, B-06934955936111, B-06934955936227, B-06934955936173, B-06934955936012, B-06934955936128
PMA Number
FDA Product Code
NWX
EMDN Code
C010401020101 Ptca balloon dilation catheters
GMDN Term
Coronary angioplasty balloon catheter, cutting/scoring
Device Class
Class III
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
630-104-1J
620-204-1J
620-154-1J
617-204-1J
635-204-1J
620-104-1J
627-204-1J
625-154-1J
640-104-1J
630-154-1J
617-104-1J
625-204-1J
GUDID
635-104-1U
Primary DI / UDI-DIEUDAMED
06934955936166
06934955936067
06934955936050
06934955936036
06934955936210
06934955936043
06934955936159
06934955936111
06934955936227
06934955936173
06934955936012
06934955936128
GUDID
06934955936432

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Cleared under the same submission (P200041)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No