Intersurgical Ltd
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000004798
Intersurgical Ltd is a medical device manufacturer based in the United Kingdom, with 257 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa, I and IIb; FDA Class II) as of 13 Nov 2026.
- Devices
- 257
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 256
- FDA GUDID 2
- FDA 510(k) 1
- Device classes
- EU Class IIa 174
- EU Class I 67
- EU Class IIb 15
- FDA Class II 1
- Top EMDN categories
- Sites and related companies
- UAB Intersurgical authorised representative
- Identifiers
- EUDAMED SRN GB-MF-000004798
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- UAB IntersurgicalLT
What Intersurgical Ltd makes
Intersurgical Ltd manufactures respiratory support devices, including heated humidifiers and positive expiratory pressure (PEP) therapy devices for airway management. Their portfolio also covers airway adjuncts such as Guedel airways, hospital masks, and infant bonnet systems, alongside tube management solutions and breathing filters like the TNI Clear-Guard™. Additional products include infant-specific respiratory aids designed for neonatal care.
The company’s devices are classified under EU regulations as Class I, Class II, and Class IIb, with corresponding authorisations in the EU via EUDAMED and FDA clearance in the US via the 510(k) pathway. These products are listed in both the EU’s eudamed registry and the FDA’s 510(k) database, reflecting their regulatory compliance in key global markets. The manufacturer is based in the United Kingdom.
Catalogue
Search and filter all 257 devicesShowing 1-50 of 257
Company details
- EUDAMED SRN
- GB-MF-000004798
- EU VAT number
- GB234236234
- EUDAMED status
- Active
- EUDAMED registered name
- Intersurgical Ltd
- Registered address
- Crane House, RG41 2RZ, Wokingham, United Kingdom (ex Northern Ireland)
- Website
- www.intersurgical.com
- PRRC contact
- Petra Batterbee
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 11 Apr 2029
TUV Rheinland Italia SRL 1936 1 certificate
- ITH 2534789 1 Active
Quality management system EU MDR
- Issued
- 24 Jul 2026
- Expires
- 11 Apr 2029
- Reason
- Other
FDA establishments
- Intersurgical, Inc. East Syracuse, NY · US FEI 1000120301
- Intersurgical SpA IT
Frequently asked questions
How many devices does Intersurgical Ltd have in the registry?
The registry currently lists 257 devices for Intersurgical Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intersurgical Ltd's devices?
Among its 50 most recently registered devices, Intersurgical Ltd has devices listed in EUDAMED (50 devices).
What risk classes do Intersurgical Ltd's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Intersurgical Ltd's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Intersurgical Ltd?
EUDAMED lists 1 certificate for Intersurgical Ltd (quality management system) under MDR. The most recent was issued on 24 Jul 2026.
What are the newest devices from Intersurgical Ltd in the registry?
The most recently registered devices listed for Intersurgical Ltd include Carbon Dioxide Absorbents, Aerosol and Oxygen Face Masks, PEEP Valves and Venturi Valves and Venturi Valve Face Mask Kits.
Which FDA establishments are linked to Intersurgical Ltd?
2 FDA establishments are linked to Intersurgical Ltd in the registry; they are listed on the company page.