Beta Healthcare Products Pvt., Ltd.
Active in EUDAMEDIndiafrom SRN EUDAMED SRN IN-MF-000019439
- Devices
- 4
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Beta Healthcare Products Pvt., Ltd. makes
Beta Healthcare Products Pvt., Ltd. manufactures latex surgeon’s gloves that are powder-free and polymer-coated, with a specified protein content of 50 micrograms per square decimeter or less per glove. These gloves include extractable protein labeling to meet low-allergeneicity standards for surgical use.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway in the United States. The manufacturer is based in the US.
Catalogue
- Regimes: CE MDR 510(k) Registry: 510(k)
Pristeen++ Ref LSGPD
Regimes: CE MDR Registry: EUDAMEDLuvas Cirúrgicas Sem Pó Originpharma Ref REF_LUVAS
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- IN-MF-000019439
- EU VAT number
- 32AACCB6179L1ZH
- EUDAMED status
- Active
- EUDAMED registered name
- Beta Health Care Products Pvt Ltd
- EUDAMED abbreviated name
- BHPL
- Registered address
- Plot No.21A, Cochin Special Economic Zone, 682037, Ernakulam, India
- [email protected]
- Phone
- 0484 241333390
- PRRC contact
- Parthasarathi S
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 25 Nov 2027
DNV Product Assurance AS 2460 1 certificate
- 10000515641-PA-NoMA-IND Suspended
Quality management system EU MDR
- Issued
- 26 Nov 2022
- Expires
- 25 Nov 2027
- Reason
- Failure contractual obligations
Frequently asked questions
How many devices does Beta Healthcare Products Pvt., Ltd. have in the registry?
The registry currently lists 4 devices for Beta Healthcare Products Pvt., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beta Healthcare Products Pvt., Ltd.'s devices?
Among its 4 most recently registered devices, Beta Healthcare Products Pvt., Ltd. has devices listed in EUDAMED (3 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Beta Healthcare Products Pvt., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Beta Healthcare Products Pvt., Ltd.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Beta Healthcare Products Pvt., Ltd.?
EUDAMED lists 1 certificate for Beta Healthcare Products Pvt., Ltd. (quality management system) under MDR. The most recent was issued on 26 Nov 2022.
What are the newest devices from Beta Healthcare Products Pvt., Ltd. in the registry?
The most recently registered devices listed for Beta Healthcare Products Pvt., Ltd. include Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein, Pristeen++, LUVAS CIRÚRGICAS SEM PÓ ORIGINPHARMA and PRISTEEN.