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Silicone Rubber Sheet 0.85mm x 65mm x 95mm (Blue)

by Exmoor Plastics Limited

Ref SRS2A(29)

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-05060180258306 Basic UDI-DI 05060180258306UDI-DIDate24 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060180258306 UDI-DI Date21 Sep 2018ListedStatusListed 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  • Withdrawn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

Trade Name
Silicone Rubber Sheet 0.85mm x 65mm x 95mm (Blue) EUDAMED
Exmoor GUDID
Generic Name
Silicone-sheet tissue reconstructive material, non-sterile
Device Name
Silicone Rubber Sheet (29 days)
Model / Ref / Catalog
SRS2A(29), SRS.2a(29)
Primary DI / UDI-DI
05060180258306
Basic UDI-DI
B-05060180258306
510(k) Number
FDA Product Code
KHJ
EMDN Code
Q0399 ENT devices - other
GMDN Term
Silicone-sheet tissue reconstructive material, non-sterile
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
874.3620
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SRS2A(29)
GUDID
SRS.2a(29)
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000025513
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Exmoor Plastics Limited

See all devices from Exmoor Plastics Limited →

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