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Sterile Surgical Gown
EUDAMEDClass I (EU MDR)
Ref 0650XXLModel Standard Style - Standard PerformanceRef F934006Ref AMSY0003Ref F934010Model Reinforced Style - Standard PerformanceRef 1999.02Model Reinforced Style - High PerformanceRef F934009Ref F931010Ref 1997.01Model Standard Style - High PerformanceRef 1998.01Ref 1996.02Ref 1998.05Ref F931003Ref 0651SRef F931009Ref 0651XLRef F934004Ref 1996.00Ref 1997.04Ref 0651MRef F934002Ref F931001Ref F934013Ref F934003Ref AMSY0007Ref F934014Ref F931005Ref AMSY0006Ref 1996.01Ref 0650XXXLRef F931008Ref 1996.04Ref F934016Ref F934011Ref F934008Ref F931012Ref 1999.04Ref F931013Ref F931004Ref F931015Ref AMSY0008Ref F934012Ref F934005Ref AMSY0004Ref 1998.06Ref AMSY0002
Identity
- Device Name
- Sterile Surgical Gown EUDAMED
- Model / Reference
- Standard Style - Standard Performance EUDAMED0650XXL EUDAMEDF934006 EUDAMEDAMSY0003 EUDAMEDReinforced Style - Standard Performance EUDAMEDF934010 EUDAMEDReinforced Style - High Performance EUDAMED1999.02 EUDAMEDF934009 EUDAMEDF931010 EUDAMEDStandard Style - High Performance EUDAMED1997.01 EUDAMED1998.01 EUDAMED1996.02 EUDAMED1998.05 EUDAMEDF931003 EUDAMED0651S EUDAMEDF931009 EUDAMED0651XL EUDAMEDF934004 EUDAMED1996.00 EUDAMED1997.04 EUDAMED0651M EUDAMEDF934002 EUDAMEDF931001 EUDAMEDF934013 EUDAMEDF934003 EUDAMEDAMSY0007 EUDAMEDF934014 EUDAMEDF931005 EUDAMEDAMSY0006 EUDAMED1996.01 EUDAMED0650XXXL EUDAMEDF931008 EUDAMED1996.04 EUDAMEDF934016 EUDAMEDF934011 EUDAMEDF934008 EUDAMEDF931012 EUDAMED1999.04 EUDAMEDF931013 EUDAMEDF931004 EUDAMEDF931015 EUDAMEDAMSY0008 EUDAMEDF934012 EUDAMEDF934005 EUDAMEDAMSY0004 EUDAMED1998.06 EUDAMEDAMSY0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08936217150103 EUDAMED08936217151131 EUDAMED08936217153067 EUDAMED08936217151360 EUDAMED08936217152237 EUDAMED08936217151353 EUDAMED08936217151681 EUDAMED08936217152305 EUDAMED08936217152060 EUDAMED08936217152039 EUDAMED08936217152107 EUDAMED08936217153050 EUDAMED08936217151544 EUDAMED08936217150158 EUDAMED08936217151667 EUDAMED08936217150196 EUDAMED08936217151087 EUDAMED08936217152381 EUDAMED08936217152367 EUDAMED08936217150165 EUDAMED08936217152398 EUDAMED08936217151049 EUDAMED08936217151506 EUDAMED08936217151438 EUDAMED08936217151070 EUDAMED08936217153135 EUDAMED08936217151452 EUDAMED08936217151582 EUDAMED08936217153128 EUDAMED08936217152053 EUDAMED08936217150134 EUDAMED08936217151643 EUDAMED08936217152404 EUDAMED08936217151490 EUDAMED08936217152077 EUDAMED08936217151391 EUDAMED08936217151179 EUDAMED08936217151711 EUDAMED08936217152251 EUDAMED08936217151742 EUDAMED08936217151568 EUDAMED08936217151773 EUDAMED08936217150110 EUDAMED08936217153159 EUDAMED08936217151407 EUDAMED08936217151100 EUDAMED08936217153081 EUDAMED08936217151810 EUDAMED08936217152145 EUDAMED08936217152299 EUDAMED08936217153036 EUDAMED
- Basic UDI-DI
- 893621715SSurgicalGownsWP EUDAMED893621715RSURGICALGOWNSXX EUDAMED893621715HSURGICALGOWNSJH EUDAMED893621715HSurgicalGownsFW EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMEDT020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDNorthern Ireland EUDAMEDPortugal EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Surgical Gown by Allmed Medical Textile Co., Ltd (viet Nam) — 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 | 893621715SSurgicalGownsWP | Class I | Active |
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Manufacturer
- Manufacturer
- Allmed Medical Textile Co., Ltd (viet Nam)
- EUDAMED SRN
- VN-MF-000033090
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (51)
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- EUDAMED 17133ab2-c95d-4116-9375-878bb9aa454e 61 fields · synced May 11, 2026
- EUDAMED 2e5646d0-d449-4c11-8a4a-b8f43e8bbc4e 61 fields · synced May 16, 2026
- EUDAMED 5026badc-aff9-4c49-add4-bda900c9a2e0 61 fields · synced May 16, 2026
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- EUDAMED af328171-660c-4aad-87c7-1a4d93df086c 61 fields · synced May 17, 2026
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- EUDAMED d7942d1a-b4e3-4556-a70e-88ee75c2b775 61 fields · synced May 17, 2026
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- EUDAMED 7609eea9-c207-421f-8bf2-d9bc16358004 61 fields · synced May 17, 2026
- EUDAMED 2142bc20-981e-4a82-bc22-c54817943ae7 61 fields · synced May 17, 2026
- EUDAMED 7e8ece01-1d4f-4d5c-9907-654c702abfe9 61 fields · synced May 18, 2026
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- EUDAMED b795db61-f20f-4c47-a76c-022877a56730 61 fields · synced May 18, 2026
- EUDAMED 8b4a5a28-6ace-48aa-bf6d-cce10102205a 61 fields · synced May 18, 2026
- EUDAMED c3b06193-d48f-4c65-aea4-d5ef2ab4d00f 61 fields · synced May 18, 2026
- EUDAMED 8b050448-cb7b-462c-bc9b-baf8d458ae46 61 fields · synced May 18, 2026
- EUDAMED 390d8e1d-bf6e-4af7-9b18-fd10cdd65374 61 fields · synced May 18, 2026
- EUDAMED 256a871f-4886-4a3c-8da4-9044ff6b773a 61 fields · synced May 18, 2026
- EUDAMED 0873f818-8821-4b14-be6f-a5ba1740fd66 61 fields · synced May 18, 2026
- EUDAMED 49aba1ca-0422-4cc1-a20d-3156c8d93b53 61 fields · synced May 18, 2026
- EUDAMED 3a29424a-e3b5-4e5e-bc7e-66b7d0285f1a 61 fields · synced May 19, 2026