Identity
- Trade Name
- Pristeen EUDAMED
- Device Name
- Latex Surgical Gloves Powdered - Pristeen, Perfekto, Protezine, Luvas COM PO Originpharma EUDAMED
- Model / Reference
- 5.5 TO 9.0 EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908000843240 EUDAMED
- Basic UDI-DI
- 8908000843LSGPD9A EUDAMED
- EMDN Code
- T01010101 POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pristeen by Beta Health Care Products Pvt Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8908000843LSGPD9A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beta Health Care Products Pvt Ltd
- EUDAMED SRN
- IN-MF-000019439
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 92f7b1ad-6225-4a54-80de-bf3fa4943d51 61 fields · synced May 23, 2026