Identity
- Trade Name
- Pristeen++ EUDAMED
- Device Name
- Latex Surgical Gloves Powdered - Pristeen++, Surgilex Plus, Pristeen, Easy flow EUDAMED
- Model / Reference
- Size 5.5 to 9.0 EUDAMEDLSGPD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908019791167 EUDAMED
- Basic UDI-DI
- 89080197910LSGPDEG EUDAMED
- Direct Marketing DI
- 08908019791167 EUDAMED
- EMDN Code
- T01010101 POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 | 89080197910LSGPDEG | 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 0dd9906b-08b9-4a31-be9a-0678bdd43785 61 fields · synced May 23, 2026