Enztec Limited
Active in EUDAMEDNew Zealandfrom SRN EUDAMED FDA SRN NZ-MF-000002264 FEI 3004641308
Enztec Limited is a medical device manufacturer based in New Zealand, with 1,041 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class I and II; EU Class I and IIa) and 1 FDA recall as of 14 Nov 2026.
- Devices
- 1,041
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
Registry facts
- Registries
- EUDAMED 819
- FDA GUDID 750
- FDA 510(k) 4
- Device classes
- FDA Class I 521
- EU Class I 399
- EU Class IIa 116
- FDA Class II 5
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Advena Limited authorised representative
- Identifiers
- EUDAMED SRN NZ-MF-000002264
- FDA FEI 3004641308
- DUNS 592616445
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Advena LimitedMT
Catalogue
Search and filter all 1,041 devicesShowing 1-50 of 1,041
Company details
- EUDAMED SRN
- NZ-MF-000002264
- FDA FEI number
- 3004641308
- DUNS number
- 592616445
- EUDAMED status
- Active
- EUDAMED registered name
- Enztec Limited
- EUDAMED abbreviated name
- Enztec
- Registered address
- 3/17, Print Place, 8024, Christchurch, New Zealand
- kate@enztec.co.nz
- PRRC contact
- Kate Moorhead
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 5 Aug 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 724378 Active
Quality management system EU MDR
- Issued
- 29 Jul 2025
- Expires
- 5 Aug 2030
- Valid from
- 6 Aug 2025
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 16 Aug 2019 Z-0612-2020 Class II Terminated The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.
Frequently asked questions
How many devices does ENZTEC LIMITED have in the registry?
The registry currently lists 1041 devices for ENZTEC LIMITED. Devices recorded under merged duplicate company entries are counted once.
Which registries list ENZTEC LIMITED's devices?
Among its 50 most recently registered devices, ENZTEC LIMITED has devices listed in EUDAMED (18 devices) and FDA GUDID (36 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ENZTEC LIMITED's devices fall under?
Among its 50 most recently registered devices, the classes recorded for ENZTEC LIMITED's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
Are there FDA recall records for ENZTEC LIMITED?
FDA recall records list 1 recall initiated by ENZTEC LIMITED, the most recent initiated on 16 Aug 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for ENZTEC LIMITED?
EUDAMED lists 1 certificate for ENZTEC LIMITED (quality management system) under MDR. The most recent was issued on 29 Jul 2025.
What are the newest devices from ENZTEC LIMITED in the registry?
The most recently registered devices listed for ENZTEC LIMITED include Tibia Proximal Rod Assembly - Shortened, Ossis Cup Inserter Lug, Tibial Finishing Impactor Head and Anterior Retractor.