Skip to content

Su-Por Surgical Implants

by Poriferous, LLC 37 variants

Ref 4770

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

CE MDR

Valid until

20 Jul 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

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 Number00815285025163 UDI-DI Date13 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081528502SUPORDJ Basic UDI-DI 00815285025163UDI-DIDate19 Nov 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000144460 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    21 Jul 2025
    Expires
    20 Jul 2030
  • 1000257608 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    21 Jul 2025
    Expires
    20 Jul 2030

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Su-Por Surgical Implants EUDAMED
SU-POR Surgical Implant GUDID
Generic Name
Polyethylene craniofacial tissue reconstructive material
Model / Ref / Catalog
4770
Primary DI / UDI-DI
00815285025163
Basic UDI-DI
081528502SUPORDJ
510(k) Number
FDA Product Code
KKY
EMDN Code
P900403 Non-resorbable filling and reconstruction devices
GMDN Term
Polyethylene craniofacial tissue reconstructive material
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.3500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000016703
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Poriferous, LLC

See all devices from Poriferous, LLC →

Properties

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

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Serial Number: No