FDA Registration
Active
🇨🇳 China
AUTOLOGIC PUMP (SUZHOU - SPEC.DEV & POZNAN - COMPLAINTS)
Reg #: 3005619970
·
FEI: 3005619970
·
Expires 2025
Products
1
Proprietary Names
36
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Arjo (Suzhou) Co., Ltd.
- Registration Number
- 3005619970
- FEI Number
- 3005619970
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 158 Fangzhou Road, SIP, Suzhou, Jiangsu,
- City
- Suzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- ARJOHUNTLEIGH AB
- Operator Number
- 8010077
- Address
- Hans Michelsensgatan 10
- City
- Malmo
- State
- Skane
- Postal Code
- 211 20
- Country
- SE
US Agent
- Business Name
- Arjo Inc
- Contact Name
- Darren Demerritt
- Address
- 2349 W Lake St, #250
- City
- Addison
- State
- IL
- ZIP
- 60101
- Country
- US
- [email protected]
- Phone
- 425 3089587
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2002-08-15 |
Proprietary Names
AUTOLOGIC PUMP (SUZHOU - SPEC.DEV & POZNAN - COMPLAINTS)
ATMOSAIR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
MAXXAIR ETS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
AUTOLOGIC MATTRESS (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
NIMBUS PRO MATTRESS (SUZHOU - MFR & POZNAN - COMPLAINTS)
ALPHA RESPONSE PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
PROFICARE (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
FIRST STEP SELECT PUMP (SUZHOU - MANUFACTURER & POZNAN - COMPLAINTS)
BREEZE PUMP (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
NIMBUS 3 MATTRESS (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
THERAKAIR VISIO PUMP (POZNAN - COMPLAINTS)
ALPHA TRANCELL DELUXE PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS)
NIMBUS 4 PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS)
THERAKAIR VISIO MATTRESS (POZNAN - COMPLAINTS)
ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN - SPEC.DEVELOPER & POZNAN - COMPLAINTS)
BUBBLE PAD MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
ATMOSAIR 9000AR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
AURA PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS)
FIRST STEP SELECT MATTRESSES (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
AURA CUSHION (SUZHOU - MFR & POZNAN - COMPLAINTS)
ALPHA RESPONSE MATTRESS (POZNAN - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
BREEZE MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
NIMBUS 3 PUMP (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
CITADEL CONTROL UNIT AND MATTRESS (SUZHOU - SPEC. DEVELOPER & MANUFACTURER, POZNAN - COMPLAINTS, POZNAN - FOREIGN EXP)
FIRST STEP CIRRUS OVERLAY (SUZHOU - MFR & POZNAN - COMPLAINTS)
FIRST STEP ALL IN ONE (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
FIRST STEP SELECT HD (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
NIMBUS 4 MATTRESS ASSEMBLY RELIANT IS2 (SUZHOU - MFR & POZNAN - COMPLAINTS)
ATMOSAIR 9000A (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
ATMOSAIR APOD (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
FIRST STEP PLUS (SUZHOU - MFR & POZNAN - COMPLAINTS)
AURALIS PUMP (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS)
AURALIS MATTRESSES (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS)
ATMOSAIR VELARIS MATTRESSES (POZNAN MFR, POZNAN COMPLAINTS)
ATMOSAIR VELARIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS)
CAYLIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS); CAYLIS MATTRESSES (SUZHOU MFR, POZNAN COMPLAINTS)
Establishment Types
Manufacture Medical Device