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Blake 2212

by Ethicon Inc.

Ref 2212Model Drains

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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/MDR EUDAMED Number0705031a020554Q Basic UDI-DI 10705031003484UDI-DIDate14 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031003484 UDI-DI Date23 Sep 2015ListedStatusListed 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.

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  • Withdrawn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
Blake
Generic Name
Closed-wound drain, non-bioabsorbable
Device Name
J-VAC Closed Wound Drainage Products and Accessories (Including BLAKE Drains)
Model / Ref / Catalog
2212, Drains
Description
Blake Silicone Drain, 7 mm flat, full fluted with 3/16" trocar
Primary DI / UDI-DI
10705031003484
Basic UDI-DI
0705031a020554Q
FDA Product Code
GBX
EMDN Code
A0601010102 Drainage systems with reservoir
GMDN Term
Closed-wound drain, non-bioabsorbable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4200
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

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Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Endocrine Disruptor
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • 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
  • Serial Number: No
  • Manufacturing Date: No