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Biotech Inc

Active in EUDAMED
Also registered as Bio-Tech Co.

United Statesfrom SRN EUDAMED SRN US-MF-000002378

Part of Biotech GmbH

Biotech Inc is a medical device manufacturer based in the United States, with 20 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) as of 15 Nov 2026.

Devices
20
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 17
  • EUDAMED 2
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 17
  • EU Class IIa 2
  • FDA Class I 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000002378

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
Authorised rep.
Atlantico Systems, Ltd.IE

Catalogue20

Newest first, rows 1-20 of 20

Search and filter all 20 devices
Skip device list

  • Cryolock(Lg) Cl-R-Ct(Lg)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cryolock(Pk) Cl-R-Ct(Pk)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cryolock(Pr) Cl-R-Ct(Pr)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-Cryolock(Lg) S-Cl(Lg)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-Cryolock (Pk) S-Cl (Pk)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-Cryolock (Pr) S-Cl (Pr)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cryolock(O) Cl-R-Ct(O)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-Cryolock (G) S-Cl (G)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cryolock(G) CL-R-CT(G)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cryolock(Y) Cl-R-Ct(Y)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-Cryolock (O) S-Cl (O)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-Cryolock (Y) S-Cl (Y)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cryolock(C) Cl-R-Ct(C)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cryolock(B) CL-R-CT(B)

    Active Regimes: CE MDR 510(k) Registry: GUDID Class:II

  • S-Cryolock (B) S-Cl (B)

    Active Regimes: 510(k) Registry: GUDID Class:II

  • S-Cryolock (C) S-Cl (C)

    Active Regimes: CE MDR 510(k) Registry: GUDID Class:II

  • Fx-Cablelok System Ref K922142

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Consti-Ssage Vibrator/Massage Ref K900674

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cryolock Ref CL-R-CT

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

  • S-Cryolock Ref S-CL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 1-20 of 20

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000002378
EUDAMED status
Active
EUDAMED registered name
Biotech Inc
Registered address
5975, Shiloh Road, 30005, Alpharetta, United States
Phone
+1 678 341 8136
PRRC contact
Carina Castillo(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 8 Nov 2027

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 755826 Expiring Expires in 358 days

    Quality assurance EU MDR

    Issued
    9 Nov 2022
    Expires
    8 Nov 2027

Frequently asked questions

How many devices does Biotech Inc have in the registry?

The registry currently lists 20 devices for Biotech Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biotech Inc's devices?

Among its 20 most recently registered devices, Biotech Inc has devices listed in EUDAMED (2 devices), FDA 510(k) (2 devices) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Biotech Inc's devices fall under?

Among its 20 most recently registered devices, the classes recorded for Biotech Inc's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Biotech Inc?

EUDAMED lists 1 certificate for Biotech Inc (quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 9 Nov 2022.

What are the newest devices from Biotech Inc in the registry?

The most recently registered devices listed for Biotech Inc include CRYOLOCK(LG) CL-R-CT(LG), CRYOLOCK(PK) CL-R-CT(PK), CRYOLOCK(PR) CL-R-CT(PR) and S-CRYOLOCK(LG) S-CL(LG).

Generated automatically from registry data and not verified by a human reviewer.