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Atos Medical AB

Sweden·SE-MF-000000725

Last updated September 17, 2026

Information

Country
Sweden
Address
8, Kraftgatan, Hörby, Sweden
LinkedIn
—
Facebook
—
Phone
+4641519800
PRRC Contact
Camilla Hjort Pagh
EUDAMED SRN
SE-MF-000000725
FDA FEI Number
3002806269
DUNS Number
355470923

Catalogue (65)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Provox Adhesive FlexiDerm Round 7253ES
EUDAMED
Class IActive
Freevent Neckband, one-piece, small 1651
EUDAMED
Class IActive
Provox Life Oxygen (10 pcs) 7620
EUDAMED
Class IIaActive
Freevent Neckband, one-piece, large 1661
EUDAMED
Class IActive
Provox Life Oxygen (30 pcs) 7621
EUDAMED
Class IIaActive
Freevent Dressing Foam 65x70 1431
EUDAMED
Class IActive
Provox Protector Small White 7385
EUDAMED
Class IActive
Provox Life FreeHands HME 7440
EUDAMEDFDA UDI
Class IActive
Provox Protector Slim Large White 7389
EUDAMED
Class IActive
TheraBite Bite Pad, Edentulous (4 pcs) PA002
EUDAMEDFDA UDI
Class IActive
Provox Protector Air Large White 7393
EUDAMED
Class IActive
Provox FreeHands Support Starter Set 8020
EUDAMEDFDA UDI
Class IActive
Provox Micron HME (30 pcs) 7248
EUDAMEDFDA UDI
Class IActive
Provox Protector Large White 7386
EUDAMED
Class IActive
Provox(tm) Voice Prosthesis K940638
FDA 510(k)
Class IIActive
Provox Vega Puncture Set K131947
FDA 510(k)
Class IIActive
ProTrach Dualcare K151404
FDA 510(k)
Class IIActive
Sinoject Maxillary Sinus Puncture & Irrigation Sys K922145
FDA 510(k)
Class IActive
Provox Vega, Model 8130-8135 K090455
FDA 510(k)
Class IIActive
Provox Activalve (size 4.5mm, 6mm, 8mm, 10mm, 12.5mm) K092593
FDA 510(k)
Class IIActive
Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251 K014102
FDA 510(k)
Class IIActive
Provox Freehands Hme, Model 7710 K022125
FDA 510(k)
Class IIActive
Provox Freehands Flexivoice K141380
FDA 510(k)
Class IIActive
Provox 2 Voice Prosthesis System K971244
FDA 510(k)
Class IIActive
Sinovent Maxillary Sinus Drainage System K896630
FDA 510(k)
Class IActive
Tympovent K936275
FDA 510(k)
Class IIActive
Sinojet Maxillary Sinus Puncture & Irrigation System K942495
FDA 510(k)
Class IActive
Provox Nid Voice Rehabilitation System, Model Ref 7101 To 7134 K043138
FDA 510(k)
Class IIActive
Provox FreeHands Support Deep 8023
EUDAMEDFDA UDI
Class IActive
Provox Micron HME (5 pcs) 7247
EUDAMEDFDA UDI
Class IActive
Provox Protector Air Small White 7391
EUDAMED
Class IActive
Provox Flush 8109
EUDAMEDFDA UDI
Class IActive
TheraBite Jaw Motion Rehabilitation System, Adult TH001
EUDAMEDFDA UDI
Class IActive
Provox BasePlate Adaptor 7263
EUDAMEDFDA UDI
Class IActive
Provox Protector Slim Large Blue 7390
EUDAMED
Class IActive
Provox Swab XtraLarge 8258
EUDAMED
Class IActive
Provox Protector Air Small Blue 7392
EUDAMED
Class IActive
Provox Protector Slim Small White 7387
EUDAMED
Class IActive
Provox Protector Air Large Blue 7394
EUDAMED
Class IActive
Provox Swab Small 8250
EUDAMED
Class IActive
Provox HME Cassette Adaptor 7246
EUDAMEDFDA UDI
Class IActive
Provox Protector Slim Small Blue 7388
EUDAMED
Class IActive
Provox Luna Adhesive 8014
EUDAMEDFDA UDI
Class IActive
Provox Adhesive Strip 8015
EUDAMEDFDA UDI
Class IActive
TheraBite Bite Pad, Pediatric (4 pcs) PA003
EUDAMEDFDA UDI
Class IActive
Provox TubeBrush 12 mm 7661
EUDAMEDFDA UDI
Class IActive
TheraBite Bite Pad, Regular (4 pcs) PA001
EUDAMEDFDA UDI
Class IActive
Provox Swab Medium 8251
EUDAMED
Class IActive
Provox FreeHands HME Flow (30 pcs) 8221
EUDAMEDFDA UDI
Class IActive
Provox HME Cap 7730
EUDAMEDFDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Atos Medical Inc. US