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Emblation, Ltd.

Active in EUDAMED
Also registered as EMBLATION LIMITED

United Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000021381

Emblation, Ltd. is a medical device manufacturer based in the United Kingdom, with 6 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I and IIb; FDA Class II) as of 14 Nov 2026.

Devices
6
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 4
  • FDA GUDID 4
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • EU Class I 2
  • EU Class IIb 2
  • FDA Class II 2
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN GB-MF-000021381

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment
Authorised rep.
Emergo Europe B.V.NL

Catalogue6

Newest first, rows 1-6 of 6

  • swiftPro System Ref K222388

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

  • Swift System Ref K181941

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

  • Swift® Ref SWF-HP01

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIb

  • Swift® Ref SWF-AT01-10

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Swift® Ref SWF-GE01

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIb

  • Swift® Ref SWF-AT01

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
GB-MF-000021381
EU VAT number
937 8397 63
EUDAMED status
Active
EUDAMED registered name
Emblation Ltd
Registered address
Castle Business Park, FK9 4TS, Stirling, United Kingdom (ex Northern Ireland)
Phone
+44 (1786) 657200
PRRC contact
Fiona Gould(public in EUDAMED)

FDA establishments1

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

  • Emblation Limited Lincoln, RI · US FEI 3015152398

Frequently asked questions

How many devices does Emblation, Ltd. have in the registry?

The registry currently lists 6 devices for Emblation, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Emblation, Ltd.'s devices?

Among its 6 most recently registered devices, Emblation, Ltd. has devices listed in EUDAMED (4 devices), FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Emblation, Ltd.'s devices fall under?

Among its 6 most recently registered devices, the classes recorded for Emblation, Ltd.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Emblation, Ltd. in the registry?

The most recently registered devices listed for Emblation, Ltd. include swiftPro System, Swift System and Swift®.

Which FDA establishments are linked to Emblation, Ltd.?

1 FDA establishment is linked to Emblation, Ltd. in the registry; they are listed on the company page.

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