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Post-Surgical Bra - EUDAMED Registration 00817612020452

Access comprehensive regulatory information for Post-Surgical Bra in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00817612020452 and manufactured by Dale Medical Products, Inc. in United States.

This page provides complete registration details including trade name (Dale Post-Surgical Bra, Medium), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
00817612020452
No
Post-Surgical Bra
Trade Name: Dale Post-Surgical Bra, Medium
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Device Description (EMDN)

ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M030499
Trade Name
Dale Post-Surgical Bra, Medium
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00817612020452
Basic UDI
0817612027026L
Version Date
March 09, 2022
Manufacturer Last Update
January 17, 2022
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
40 Kenwood Circle 02038 Franklin
Email
r.gruneberg@dalemed.net
Authorized Representative
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No