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Na Ep-2100A

by Summit Medical, LLC

Ref EP-2100A

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00385640023863 Basic UDI-DI 00385640023863UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00385640023863 UDI-DI Date11 Oct 2016ListedStatusListed 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 23 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  • Withdrawn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

Generic Name
Middle ear decompressor, positive pressure
Device Name
EarPopper
Model / Reference
EP-2100A
Primary DI / UDI-DI
00385640023863
Basic UDI-DI
B-00385640023863
510(k) Number
FDA Product Code
MJV
EMDN Code
Q030499 Otology devices - other
GMDN Term
Middle ear decompressor, positive pressure
Device Class
Class IIb EUDAMED
U GUDID
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
U
SterileEUDAMED
Yes
GUDID
No

Related devices

Category: Middle ear decompressor, positive pressure

Cleared under the same submission (K073401)

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (18)

  • Single Use: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No