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Meril Healthcare Pvt., Ltd.

Active in EUDAMED

Indiafrom SRN EUDAMED FDA SRN IN-MF-000006106

Devices
42
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA establishment

What Meril Healthcare Pvt., Ltd. makes

Meril Healthcare manufactures orthopedic implants, including total hip and knee replacement systems such as the Latitud Hip Replacement System and the Destiknee Total Knee System. Their portfolio also includes titanium-niobium-nitrogen (TiNbN) coated knee implants and a range of fracture fixation devices, including plates and screws for bones like the clavicle, humerus, tibia, olecranon, and calcaneus.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue42

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Company details

EUDAMED SRN
IN-MF-000006106
EUDAMED status
Active
EUDAMED registered name
Meril Healthcare Pvt. Ltd.
EUDAMED abbreviated name
MHC
Registered address
Meril Campus, B. No. 8 - F1, B. No. 10, B. No. 5 – F0, B. No. 6 - F2, 396191, Vapi, India
Phone
+91-260-3052100
PRRC contact
Umesh Sharma(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 16 Mar 2031

EUDAMED certificates (1)

SZUTEST Konformitätsbewertungsstelle GmbH 2975 1 certificate

  • 2975-MED-2607601 Active Amended

    Quality management system EU MDR

    Issued
    19 Aug 2026
    Expires
    16 Mar 2031
    Reason
    Mnf data change

FDA establishments1

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

  • Meril Healthcare Pvt. Ltd. Vapi Gujarat · IN FEI 3010846112

Frequently asked questions

How many devices does Meril Healthcare Pvt., Ltd. have in the registry?

The registry currently lists 42 devices for Meril Healthcare Pvt., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Meril Healthcare Pvt., Ltd.'s devices?

Among its 42 most recently registered devices, Meril Healthcare Pvt., Ltd. has devices listed in EUDAMED (35 devices) and FDA 510(k) (7 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Meril Healthcare Pvt., Ltd.'s devices fall under?

Among its 42 most recently registered devices, the classes recorded for Meril Healthcare Pvt., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Meril Healthcare Pvt., Ltd.?

EUDAMED lists 1 certificate for Meril Healthcare Pvt., Ltd. (quality management system) under MDR. The most recent was issued on 19 Aug 2026.

What are the newest devices from Meril Healthcare Pvt., Ltd. in the registry?

The most recently registered devices listed for Meril Healthcare Pvt., Ltd. include BONE CUTTER 6.2 MM- Accessories (Consumables) for MISSO® Orthopedic Robotic System, JOINT SEPARATOR- Instruments for MISSO® Orthopedic Robotic System, DRILL GUIDE PUNCH- Instruments for MISSO® Orthopedic Robotic System and MISSO ROBOT CART ARTICULATED ARM LONG- Instruments for MISSO® Orthopedic Robotic System.

Which FDA establishments are linked to Meril Healthcare Pvt., Ltd.?

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

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