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Alternating Pressure Mattress
EUDAMEDClass I (EU MDR)
Ref S10-4545-2Model EFFECE250 EFFECT250F EFFECT250V EFFECT250VF EFFECT350 EFFECT400 EFFECT500 EFFECT520 EFFECT540 EFFECT560 EFFECT820 EFFECT840 EFFECT860 EFFECT960Ref S10-5045-1Ref S05-5045-1Ref EFFECT560Ref S10-4040-1Ref S10-4545-1Ref S06-5040-1Ref EFFECT250VFRef S05-4545-2Ref EFFECT840Ref S06-4540-1Ref S10-4540-1Ref S05-4540-1Ref S07-4040-1Ref S07-5040-1Ref S05-4040-1Ref S06-4540-2Ref S07-5040-2Ref S10-5045-2Ref S07-4040-2Ref S05-4540-2Ref EFFECT250FRef EFFECT250VRef EFFECT350Ref EFFECE250Ref S05-4545-1Ref S07-5045-1Ref S10-5040-2
Identity
- Trade Name
- Alternating Pressure Mattress EUDAMED
- Device Name
- Alternating Pressure Mattress EUDAMED
- Model / Reference
- EFFECE250 EFFECT250F EFFECT250V EFFECT250VF EFFECT350 EFFECT400 EFFECT500 EFFECT520 EFFECT540 EFFECT560 EFFECT820 EFFECT840 EFFECT860 EFFECT960 EUDAMEDS10-4545-2 EUDAMEDS10-5045-1 EUDAMEDS05-5045-1 EUDAMEDEFFECT560 EUDAMEDS10-4040-1 EUDAMEDS10-4545-1 EUDAMEDS06-5040-1 EUDAMEDEFFECT250VF EUDAMEDS05-4545-2 EUDAMEDEFFECT840 EUDAMEDS06-4540-1 EUDAMEDS10-4540-1 EUDAMEDS05-4540-1 EUDAMEDS07-4040-1 EUDAMEDS07-5040-1 EUDAMEDS05-4040-1 EUDAMEDS06-4540-2 EUDAMEDS07-5040-2 EUDAMEDS10-5045-2 EUDAMEDS07-4040-2 EUDAMEDS05-4540-2 EUDAMEDEFFECT250F EUDAMEDEFFECT250V EUDAMEDEFFECT350 EUDAMEDEFFECE250 EUDAMEDS05-4545-1 EUDAMEDS07-5045-1 EUDAMEDS10-5040-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979080640410 EUDAMED06979080640427 EUDAMED06979080640526 EUDAMED06979080640106 EUDAMED06979080640342 EUDAMED06979080640403 EUDAMED06979080640182 EUDAMED06979080640045 EUDAMED06979080640519 EUDAMED06979080640120 EUDAMED06979080640168 EUDAMED06979080640366 EUDAMED06979080640465 EUDAMED06979080640243 EUDAMED06979080640281 EUDAMED06979080640441 EUDAMED06979080640175 EUDAMED06979080640298 EUDAMED06979080640434 EUDAMED06979080640250 EUDAMED06979080640472 EUDAMED06979080640021 EUDAMED06979080640038 EUDAMED06979080640052 EUDAMED06979080640014 EUDAMED06979080640502 EUDAMED06979080640328 EUDAMED06979080640397 EUDAMED
- Basic UDI-DI
- 697908064SBHMSP EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Alternating Pressure Mattress by ShengBaiHui (Zhangzhou) Medical Technology 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 | 697908064SBHMSP | Class I | Active |
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Manufacturer
- Manufacturer
- ShengBaiHui (Zhangzhou) Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000049081
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (28)
- EUDAMED c1ef3763-2b0b-478d-925e-3cd16c47c780 61 fields · synced Oct 6, 2026
- EUDAMED d103e999-a22a-45cf-9f6b-a34104fb2206 61 fields · synced May 16, 2026
- EUDAMED 30099d74-5cdf-4086-9dc7-0a7553ef32c9 61 fields · synced May 16, 2026
- EUDAMED b05a9f60-5da1-4233-a8d8-669f575dad44 61 fields · synced May 16, 2026
- EUDAMED 61a168ee-24a0-4638-85ad-cbad9b18ec2e 61 fields · synced May 16, 2026
- EUDAMED e4717042-4584-4ad6-8d14-481164d60800 61 fields · synced May 16, 2026
- EUDAMED 027d2ba3-3503-4c3e-bbfd-bc5f41320049 61 fields · synced May 17, 2026
- EUDAMED 3ac3ae63-6be0-4aae-8a09-4a7f437e5e98 61 fields · synced May 17, 2026
- EUDAMED bb4a191a-5c9a-49bd-8b33-3fe1a41d2e57 61 fields · synced May 17, 2026
- EUDAMED f551d3b2-886f-45f6-b0c1-2057a4d6eb36 61 fields · synced May 17, 2026
- EUDAMED 04880532-0bc0-4389-a53c-c6bb5d5546c4 61 fields · synced May 17, 2026
- EUDAMED 43e36310-a940-4f27-a75f-7a4964e2af41 61 fields · synced May 17, 2026
- EUDAMED a42be1cc-3fe5-44d3-82e0-cb1aa1065786 61 fields · synced May 17, 2026
- EUDAMED 8a2035b5-176d-4c8b-a658-9663ae875332 61 fields · synced May 17, 2026
- EUDAMED d21daaa6-d6ad-4a09-b390-21b671921207 61 fields · synced May 17, 2026
- EUDAMED 56a78e81-a200-48e9-b972-a43273ee801f 61 fields · synced May 17, 2026
- EUDAMED 68c0e34f-5609-462f-ba89-58299a3c6d7c 61 fields · synced May 17, 2026
- EUDAMED e060b79e-c672-4719-b745-0096fcedb3e4 61 fields · synced May 18, 2026
- EUDAMED ba1995c2-15ff-4118-8eaa-5d390f19c077 61 fields · synced May 18, 2026
- EUDAMED d12926be-3a8c-4420-bac9-4139ed557f5e 61 fields · synced May 18, 2026
- EUDAMED 40a18408-02da-46e0-828e-2e804bd1daf1 61 fields · synced May 18, 2026
- EUDAMED 5e1a61d4-6b9a-401a-950b-0fecf50ffe31 61 fields · synced May 18, 2026
- EUDAMED 0a3af01c-5307-4632-bace-b94285591f3a 61 fields · synced May 18, 2026
- EUDAMED bd0bd671-8c97-412b-9de6-a4c3c3a36b31 61 fields · synced May 18, 2026
- EUDAMED a6470bd5-43ab-4860-8e08-57ec6ef80c8e 61 fields · synced May 18, 2026
- EUDAMED 440e6e40-cd32-4efe-a231-a316d3a6ae56 61 fields · synced May 18, 2026
- EUDAMED 7e8f4d5c-54fa-4045-8968-dd7ec0c1c0e5 61 fields · synced May 19, 2026
- EUDAMED 20037aae-968e-4adc-abe7-711028a792a9 61 fields · synced May 19, 2026