Medical Indicators
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000018094
Medical Indicators is a medical device manufacturer based in the United States, with 48 devices listed in FDA GUDID and EUDAMED (FDA Class I; EU Class I) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 48
- Registrations
- EUDAMED
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 40
- EUDAMED 20
- Device classes
- FDA Class I 30
- EU Class I 18
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Advena Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000018094
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA recalls
- Authorised rep.
- Advena LimitedMT
Catalogue
Search and filter all 48 devicesCompany details
- EUDAMED SRN
- US-MF-000018094
- EUDAMED status
- Active
- EUDAMED registered name
- Medical Indicators
- EUDAMED abbreviated name
- MII
- Registered address
- 16, Thomas J Rhodes Industrial Dr, 08619, Hamilton, United States
- Website
- www.medicalindicators.com
- Phone
- 6095284341
- PRRC contact
- Alec Phipps
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 22 Mar 2028
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 761220 Active
Quality assurance EU MDR
- Issued
- 23 Mar 2023
- Expires
- 22 Mar 2028
FDA recalls
2013
- 10 Jul 2013 Z-2162-2013 Class II Terminated TempaDot products may have been mislabeled.
From the company website
Disposable thermometers with clinical accuracy, infection control, and ease of use—trusted for better patient care.
Frequently asked questions
How many devices does Medical Indicators have in the registry?
The registry currently lists 48 devices for Medical Indicators. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Indicators's devices?
Among its 48 most recently registered devices, Medical Indicators has devices listed in EUDAMED (20 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medical Indicators's devices fall under?
Among its 48 most recently registered devices, the classes recorded for Medical Indicators's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Medical Indicators?
FDA recall records list 1 recall initiated by Medical Indicators, the most recent initiated on 10 Jul 2013. 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 Medical Indicators?
EUDAMED lists 1 certificate for Medical Indicators (quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 23 Mar 2023.
What are the newest devices from Medical Indicators in the registry?
The most recently registered devices listed for Medical Indicators include TempaDOT® 2.0, C Sterile, NexTemp 4000-5, NexTemp 8500-25 and NexTemp 4003-8.