Biopor® AB 28114M

GUDID E23928114M1

No.

Dreve Otoplastik GmbH

Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made

Primary Device ID	E23928114M1
NIH Device Record Key	78364e3b-fdf2-4f36-8655-6985bd56d376
Commercial Distribution Status	In Commercial Distribution
Brand Name	Biopor® AB
Version Model Number	28114M
Catalog Number	28114M
Company DUNS	315808340
Company Name	Dreve Otoplastik GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de
Phone	+49230388070
Email	otoplastik@dreve.de

Operating and Storage Conditions

Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23928114M1 [Primary]

FDA Product Code

ESD	Hearing Aid, Air-Conduction, Prescription

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-07
Device Publish Date	2024-04-29

On-Brand Devices [Biopor® AB ]

E239282001	No.
E23928411	No.
E2392821	No.
E239288021	No.
E23928493M1	No.
E239284931	No.
E239284921	No.
E23928472M1	No.
E239284721	No.
E23928462M1	No.
E239284621	No.
E23928452M1	No.
E239284521	No.
E23928443M1	No.
E239284431	No.
E23928442M1	No.
E239284421	No.
E23928434M1	No.
E239284341	No.
E23928433M1	No.
E239284331	No.
E23928432M1	No.
E239284321	No.
E23928423M1	No.
E239284231	No.
E23928422M1	No.
E239284221	No.
E23928416M1	No.
E239284161	No.
E23928415M1	No.
E239284151	No.
E23928414M1	No.
E239284141	No.
E23928413M1	No.
E239284131	No.
E23928412M1	No.
E239284121M1	No.
E2392841211	No.
E23928401M1	No.
E239284011	No.
E239284001	No.
E239284121	No.
E23928400M1	No.
E239283911	No.
E23928361M1	No.
E239283611	No.
E23928351M1	No.
E239283511	No.
E23928331M1	No.
E239283311	No.

Trademark Results [Biopor]

Mark Image Registration \| Serial	Company Trademark Application Date
BIOPOR 79212228 5367052 Live/Registered	Dreve Otoplastik GmbH 2017-05-18
BIOPOR 75842712 2484486 Live/Registered	CEREMED, INC. 1999-11-08
BIOPOR 74322147 not registered Dead/Abandoned	BIOTEC Biologische Naturverpackungen GmbH & Co. Produktions- und Marketing KG 1992-10-14
BIOPOR 73052239 1029987 Dead/Expired	POREX MATERIALS CORPORATION 1975-05-13