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Sleeve Cover - SBPP Coated
EUDAMEDClass I (EU MDR)
Ref Sleeve Cover - SBPP CoatedModel Sleeve Cover - PE, Sleeve Cover - PVC, Sleeve Cover - SBPP, Sleeve Cover - SBPP Coated, Sleeve Cover - SBPP coated with Micro-porous filmRef Sleeve Cover - SBPPRef Sleeve Cover - SBPP coated with Micro-porous film
Identity
- Trade Name
- Sleeve Cover - SBPP Coated EUDAMEDSleeve Cover - SBPP EUDAMEDSleeve Cover - SBPP coated with Micro-porous film EUDAMED
- Device Name
- Sleeve Cover EUDAMED
- Model / Reference
- Sleeve Cover - PE, Sleeve Cover - PVC, Sleeve Cover - SBPP, Sleeve Cover - SBPP Coated, Sleeve Cover - SBPP coated with Micro-porous film EUDAMEDSleeve Cover - SBPP Coated EUDAMEDSleeve Cover - SBPP EUDAMEDSleeve Cover - SBPP coated with Micro-porous film EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00697549344285 EUDAMED00697549344278 EUDAMED00697549344292 EUDAMED
- Basic UDI-DI
- 697549344SLEEVECOVERS8J EUDAMED
- Direct Marketing DI
- 00697549344285 EUDAMED00697549344278 EUDAMED00697549344292 EUDAMED
- EMDN Code
- T030599 HEALTH SERVICE PREMISES PROTECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Sleeve Cover - SBPP Coated by Carestone Medical & Protective Products Co., Ltd. — Class I — 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 | 697549344SLEEVECOVERS8J | Class I | Active |
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Manufacturer
- Manufacturer
- Carestone Medical & Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000027756
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED 1df41205-dc11-41c4-ac9d-037cc2b5e6d4 61 fields · synced Oct 6, 2026
- EUDAMED d0f82b7d-0a07-45ec-9d84-29fe483b0652 61 fields · synced May 18, 2026
- EUDAMED c0f6739f-29a4-444a-a0d1-d8a4e0cdc1b8 61 fields · synced May 18, 2026