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Sphincterotome short-wire compatible RDSP-0525-222

by Micro-Tech (Nanjing) Co., Ltd.

Ref RDSP-0525-222

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6902284SS58039QB Basic UDI-DI 06902284552180UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06902284552180 UDI-DI Date3 Apr 2023ListedStatusListed GUDID: in commercial distribution

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 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Sphincterotome short-wire compatible
Generic name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Model / reference
RDSP-0525-222
Primary DI / UDI-DI
06902284552180 EUDAMED
06932503575287 GUDID
Basic UDI-DI
6902284SS58039QB
510(k) Number
FDA product code
KNS
EMDN code
G03040202 Papillotomes / sphincterotomes, triple (or more) lumen
GMDN term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.4300
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Atherectomy Device Tip Length — 5 Millimeter
Atherectomy Cutter Length — 25 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06902284552180
GUDID
06932503575287
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Cleared under the same submission (K210934)

Show all (12)

Other devices from Micro-Tech (Nanjing) Co., Ltd.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (19)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No