# Biotech Inc

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/biotech-inc>
- Also registered as: Bio-Tech Co.
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer, Part of a group
- Registrations: EUDAMED
- EUDAMED SRN: US-MF-000002378

## Figures

- Devices: 20
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 17, EUDAMED 2, FDA 510(k) 2
- Device classes: FDA Class II 17, EU Class IIa 2, FDA Class I 1
- EMDN [U08 Gynaecological devices](https://devicerts.com/categories/emdn/U08): 2 devices

## Sites and related companies

- Part of [Biotech GmbH](https://devicerts.com/manufacturers/biotech-gmbh)
- Authorised representative: [Atlantico Systems, Ltd.](https://devicerts.com/representatives/atlantico-systems-ltd-ie-ar-000000208) (Ireland)

## Devices

The first 20 of 20, in the order of the canonical page, which lists them all.

- [Cryolock(Lg) Cl-R-Ct(Lg)](https://devicerts.com/devices/cryolock-lg-cl-r-ct-lg-cl-r-ct-lime-green) · Class II · GUDID · status: Active
- [Cryolock(Pk) Cl-R-Ct(Pk)](https://devicerts.com/devices/cryolock-pk-cl-r-ct-pk-cl-r-ct-pink) · Class II · GUDID · status: Active
- [Cryolock(Pr) Cl-R-Ct(Pr)](https://devicerts.com/devices/cryolock-pr-cl-r-ct-pr-cl-r-ct-purple) · Class II · GUDID · status: Active
- [S-Cryolock(Lg) S-Cl(Lg)](https://devicerts.com/devices/s-cryolock-lg-s-cl-lg-s-cl-lime-green) · Class II · GUDID · status: Active
- [S-Cryolock (Pk) S-Cl (Pk)](https://devicerts.com/devices/s-cryolock-pk-s-cl-pk-s-cl-pink) · Class II · GUDID · status: Active
- [S-Cryolock (Pr) S-Cl (Pr)](https://devicerts.com/devices/s-cryolock-pr-s-cl-pr-s-cl-purple) · Class II · GUDID · status: Active
- [Cryolock(O) Cl-R-Ct(O)](https://devicerts.com/devices/cryolock-o-cl-r-ct-orange) · Class II · GUDID · status: Active
- [S-Cryolock (G) S-Cl (G)](https://devicerts.com/devices/s-cryolock-g-s-cl-green) · Class II · GUDID · status: Active
- [Cryolock(G) CL-R-CT(G)](https://devicerts.com/devices/cryolock-g-cl-r-ct-green) · Class II · GUDID · status: Active
- [Cryolock(Y) Cl-R-Ct(Y)](https://devicerts.com/devices/cryolock-y-cl-r-ct-yellow) · Class II · GUDID · status: Active
- [S-Cryolock (O) S-Cl (O)](https://devicerts.com/devices/s-cryolock-o-s-cl-orange) · Class II · GUDID · status: Active
- [S-Cryolock (Y) S-Cl (Y)](https://devicerts.com/devices/s-cryolock-y-s-cl-yellow) · Class II · GUDID · status: Active
- [Cryolock(C) Cl-R-Ct(C)](https://devicerts.com/devices/cryolock-c-cl-r-ct-clear) · Class II · GUDID · status: Active
- [Cryolock(B) CL-R-CT(B)](https://devicerts.com/devices/cryolock-b-cl-r-ct-blue) · Class II · GUDID · status: Active
- [S-Cryolock (B) S-Cl (B)](https://devicerts.com/devices/s-cryolock-b-s-cl-blue) · Class II · GUDID · status: Active
- [S-Cryolock (C) S-Cl (C)](https://devicerts.com/devices/s-cryolock-c-s-cl-clear) · Class II · GUDID · status: Active
- [Fx-Cablelok System](https://devicerts.com/devices/fx-cablelok-system-jdq-k922142) · ref K922142 · Class II · 510(k) · status: Active · decision 1992-11-20
- [Consti-Ssage Vibrator/Massage](https://devicerts.com/devices/consti-ssage-vibrator-massage-isa) · ref K900674 · Class I · 510(k) · status: Active · decision 1990-03-02
- [Cryolock](https://devicerts.com/devices/cryolock-cl-r-ct) · ref CL-R-CT · Class IIa · EUDAMED, GUDID · status: Active
- [S-Cryolock](https://devicerts.com/devices/s-cryolock-s-cl) · ref S-CL · Class IIa · EUDAMED · status: Active

## EU certificates

- MDR 755826 · Quality assurance · MDR · notified body BSI Group The Netherlands B.V. · issued 2022-11-09 · expires 2027-11-08 · status: issued

## Source and citation

- Cite as: Biotech Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/biotech-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/biotech-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/biotech-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.