FDA Registration Active 🇩🇪 Germany

MEDEALIS GMBH

Reg #: 3017064961 · FEI: 3017064961 · Expires 2026
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3

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Registration Details

Registration Name
MEDEALIS GMBH
Registration Number
3017064961
FEI Number
3017064961
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Im Steinboehl 9
City
Abtsteinach Hesse
Country
DE

Regulatory Submissions

510(k) Number
K251547

Owner / Operator

Firm Name
MEDEALIS GmbH
Operator Number
10094093
Address
Im Steinboehl 9
City
Abtsteinach
State
Hesse
Postal Code
69518
Country
DE
Correspondent
Klaus Krueger

US Agent

Business Name
PAXMED INTERNATIONAL, LLC
Contact Name
Floyd Larson
Address
1925 Palomar Oaks Way Ste 210
City
Carlsbad
State
CA
ZIP
92008
Country
US
Phone
858 7921235

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA
Accessories, Implant, Dental, Endosseous NDP
Implant, Endosseous, Root-Form DZE

Proprietary Names

DESS Dental Smart Solutions

Establishment Types

Export Device to the United States But Perform No Other Operation on Device